HiResolution™ Bionic Ear System

P960058S167 · Advanced Bionics · MCM · Jul 22, 2026

Device Facts

• Record ID: P960058S167
• Device Name: HiResolution™ Bionic Ear System
• Applicant: Advanced Bionics
• Product Code: MCM
• Decision Date: Jul 22, 2026
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
P960058S167 · Jul 22, 2026	HiResolution™ Bionic Ear System	Advanced Bionics	Retrospective review of billing or medical records; Clinic or research databases; Commercial CI fitting software databases; Peer-reviewed clinical literature	The retrospective study (CR1022) and systematic literature review were used to establish safety and effectiveness for expanding the HiResolution™ Bionic Ear System indications to include single-sided deafness (SSD) and asymmetric hearing loss (AHL).	Retrospective study; Real-world data; Systematic literature review; SSD/AHL indication expansion; Audiological outcomes

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective Study of Advanced Bionics Recipient Outcomes with Single-Sided Deafness and Asymmetric Hearing Loss (CR1022); Retrospective, within-subject, repeated-measures design; Follow-up/Duration: Up to 5 years ± 6 months; Study Period: February 2002 to September 2023	Adults (13+ years) with SSD or AHL implanted with an AB CI in 2008 or later; Sample Size: 72 subjects (25 SSD, 47 AHL); Number of Sites: 6	Not applicable for this study	Improvement in CNC word recognition scores in quiet at 1 year post-activation; speech perception in noise; sound localization; SSQ; Tinnitus Handicap Inventory
Systematic Literature Review; Systematic literature review of peer-reviewed articles; Follow-up/Duration: Variable; Study Period: 2020-2025	Adult and pediatric patients with SSD or AHL; Sample Size: 1020 adults; 167 pediatric subjects; Number of Sites: Not applicable	Not applicable for this study	Speech perception in quiet and noise, sound localization, tinnitus handicap, quality of life

Indications for Use

The HiResolution™ Bionic Ear System is intended to restore a level of auditory sensation to individuals with severe-to-profound sensorineural hearing loss via electrical stimulation of the auditory nerve.

Device Story

Cochlear implant system consisting of internal receiver-stimulator/electrode array and external sound processor. External microphones capture sound; processor converts to digital signal; headpiece transmits power/data to internal implant. Implant converts digital info to electrical stimulation delivered via electrode array to auditory nerve. Used in clinic/home; operated by patient/caregiver with clinician-controlled fitting software. Output provides auditory sensation; improves speech perception, localization, and tinnitus management. Benefits include restored hearing, improved quality of life, and reduced tinnitus burden.

Clinical Evidence

Retrospective study (N=72) of SSD/AHL recipients. Primary endpoint: CNC word score improvement in quiet at 1 year post-activation. SSD cohort (N=28) mean improvement 35.7% (p<0.0001); AHL cohort (N=49) mean improvement 34.1% (p<0.0001). ~79% of SSD and 78% of AHL subjects achieved ≥10% clinically meaningful improvement. Secondary endpoints (speech-in-noise, localization, SSQ) showed positive trends. Safety profile consistent with bilateral CI indications; 78 AEs reported, 5 SAEs. Pediatric indication supported by extrapolation from adult data and literature review.

Technological Characteristics

System includes HiRes Ultra/Ultra 3D receiver-stimulators, HiFocus SlimJ/Mid-Scala electrode arrays, Naida CI Q/M series sound processors, Target CI fitting software, and AB Remote apps. Sensing via external microphones; stimulation via electrical pulses to auditory nerve. Connectivity via headpiece/antenna coil. Software-based fitting adjusts stimulation parameters.

Indications for Use

Indicated for individuals with bilateral severe-to-profound sensorineural hearing loss (≥70 dB HL for adults, ≥90 dB HL for children) or unilateral hearing loss (AHL/SSD). AHL defined as mild-to-moderately severe loss in better ear (31-65 dB HL) with ≥15 dB interaural PTA difference. SSD defined as normal/mild loss in better ear (≤30 dB HL). Adults (≥18y) require ≤20% CNC word score in ear to be implanted. Children (5-17y) require profound loss (≥90 dB HL) and ≤5% aided monosyllabic word score. Contraindicated for acoustic nerve/central pathway lesions, active infections, cochlear ossification, or profound deafness >10 years for AHL/SSD.

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

# I. GENERAL INFORMATION

Device Generic Name: Implant, Cochlear

Device Trade Name: HiResolution™ Bionic Ear System (previously CLARION Multi-Strategy™ Cochlear Implant System, Model 1.2)

Device Product Code: MCM

Applicant's Name and Address: Advanced Bionics
28515 Westinghouse Pl.
Valencia, CA 91355

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P960058/S167

Date of FDA Notice of Approval: July 22, 2026

The original PMA (P940022) was approved on March 22, 1996, indicated for adults with bilateral severe to profound sensorineural hearing loss. The original Pediatric PMA (P960058) was approved on June 26, 1997, for children as young as 12 months with profound, bilateral sensorineural deafness. On October 19, 2002, P940022 was combined into P960058. The current supplement was submitted to expand the indications for the HiResolution™ Bionic Ear System for single sided deafness or asymmetric hearing loss (SSD/AHL).

# II. INDICATIONS FOR USE

The HiResolution™ Bionic Ear System is intended to restore a level of auditory sensation to individuals with severe-to-profound sensorineural hearing loss via electrical stimulation of the auditory nerve.

# Bilateral Hearing Loss

Adults

18 years of age or older.

- Severe-to-profound, bilateral sensorineural hearing loss (≥ 70 dB HL).
- Postlingual onset of severe or profound hearing loss.
- Limited benefit from appropriately fitted hearing aids, defined as scoring 50% or less on a test of open-set sentence recognition (HINT Sentences).

Children

12 months through 17 years of age.

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- Profound, bilateral sensorineural deafness (≥ 90 dB HL).
- Use of appropriately fitted hearing aids for at least 6 months in children 2 through 17 years of age, or at least 3 months in children 12 through 23 months of age. The minimum duration of hearing aid use is waived if x-rays indicate ossification of the cochlea.
- Little or no benefit from appropriately fitted hearing aids. In younger children (< 4 years of age), lack of benefit is defined as a failure to reach developmentally appropriate auditory milestones (such as spontaneous response to name in quiet or to environmental sounds) measured using the Infant-Toddler Meaningful Auditory Integration Scale or Meaningful Auditory Integration Scale or ≤ 20% correct on a simple open-set word recognition test (Multisyllabic Lexical Neighborhood Test) administered using monitored live voice (70 dB SPL). In older children (≥ 4 years of age), lack of hearing aid benefit is defined as scoring ≤12% on a difficult open-set word recognition test (Phonetically Balanced-Kindergarten Test) or ≤ 30% on an open-set sentence test (Hearing In Noise Test for Children) administered using recorded materials in the soundfield (70 dB SPL).

## Unilateral Hearing Loss

The HiResolution™ Bionic Ear System is indicated for individuals with unilateral hearing loss who meet the following criteria:

### Asymmetric Hearing Loss (AHL)

Individuals with AHL are defined as those with a mild to moderately severe hearing loss in the better ear, i.e., a 4PTA of 31 to 65 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz, with a difference of at least 15 dB in the 4PTA between ears.

It is recommended that individuals with AHL have at least two (2) weeks experience wearing an appropriately fitted Contralateral Routing of Signal (CROS) system or suitable hearing device prior to cochlear implantation.

The ear to be implanted will be as follows:

Adults (18 years of age or older):

- Severe to profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz ≥ 80 dB HL)
- A score of ≤ 20% on a Consonant-Nucleus-Consonant (CNC) word test

Children (5 years through 17 years of age):

- Profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz ≥ 90 dB HL)
- Insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 5% or less on a developmentally appropriate monosyllabic word list when tested in the ear to be implanted alone.

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# **Single-Sided Deafness (SSD)**

Individuals with SSD are defined as those with normal hearing or mild sensorineural hearing loss in the better ear (4PTA of ≤ 30 dB HL at 500, 1000, 2000, and 4000 Hz).

It is recommended that individuals with SSD have at least two (2) weeks experience wearing an appropriately fitted Contralateral Routing of Signal (CROS) system or suitable hearing device prior to cochlear implantation.

The ear to be implanted will be as follows:

Adults (18 years of age or older):

- Severe to profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz ≥ 80 dB HL)
- A score of ≤ 20% on a Consonant-Nucleus-Consonant (CNC) word test

Children (5 years through 17 years of age):

- Profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz ≥ 90 dB HL)
- Insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 5% or less on a developmentally appropriate monosyllabic word list when tested in the ear to be implanted alone.

### III. CONTRAINDICATIONS

The HiResolution™ Bionics Ear system is not suitable for individuals with the following conditions:

- Deafness due to lesions of the acoustic nerve or central auditory pathway;
- Active external or middle ear infections;
- Cochlear ossification that prevents electrode insertion;
- Absence of cochlear development;
- Tympanic membrane perforations associated with recurrent middle ear infections
- For individuals with AHL/SSD, duration of profound deafness > 10 years

### IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the HiResolution™ Bionic Ear System labeling.

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## V. DEVICE DESCRIPTION

No design changes to the approved devices in the HiResolution™ Bionic Ear System are required for the new indication.

The HiResolution™ Bionic Ear System is a cochlear implant (CI) designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of the following main components:

○ CIs (consisting of a receiver stimulator, an antenna coil with a magnet, and an electrode array):

- HiRes™ Ultra series
- HiRes™ Ultra 3D series

○ Sound Processors

- Naida CI Q series
- Naida CI M series

○ Fitting Software:

- Target CI

○ Applications

- AB Remote
- AB Remote Support


Figure 1: Advanced Bionics external sound processor (left) and internal electrode array (right)

A CI system consists of one internal component and an external sound process and accessories (see Figure 1). The internal components include the HiRes Ultra and HiRes Ultra 3D receiver with either the HiFocus SlimJ or the HiFocus Mid-Scala electrode array that are implanted surgically under the skin behind the ear (see Figure 1).

In the HiResolution™ Bionic Ear System, sound is captured by external microphones and is converted into a digital signal CIs can receive sound from T-Mic, headpiece and processor microphones and auxiliary audio input sources). The external processor sends power and digital information via the headpiece to the internal implant, which is implanted under the skin. The internal implant converts the digital information into electrical stimulation which is delivered to the auditory nerve through the electrode array

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implanted in the cochlear. These electrical signals stimulate the auditory nerve, sending impulses to the brain where they are interpreted as sound.

Within the HiResolution™ Bionic Ear System, clinician-controlled fitting software is used to adjust stimulation parameters based on the individual user's auditory needs.

## VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the correction of SSD/AHL conditions. These treatments include bone conduction hearing aids, bone anchored hearing aids, implantable bone conduction hearing aids, and CROS hearing aids. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.

## VII. MARKETING HISTORY

The HiResolution™ Bionic Ear System was first approved in the United States in March 1996 (originally as the CLARION Multi-Strategy™ Cochlear Implant System).

The indications for use in countries other than the US do not have identical age or audiometric indications. Countries with unilateral and bilateral indications include Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Iran, Israel, Italy, Kazakhstan, South Korea, Lithuania, Luxembourg, Morocco, Netherlands, Norway, Oman, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovenia, Sweden, Tunisia, Ukraine, South Africa, Canada, United Arab Emirates, Hong Kong, Indonesia, India, Myanmar, Malaysia, New Zealand, Singapore, Taiwan, Vietnam, and Australia.

The devices have not been withdrawn from any market due to a change in indications for any reason related to safety or effectiveness.

## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Below is a list of the potential adverse effects (e.g., complications) associated with the implantation and use of the HiResolution™ Bionic Ear System:

- Implant recipients incur the normal risks of surgery and general anesthesia.
- Major ear surgery may result in numbness, swelling or discomfort around the ear, disturbance of taste or balance, or pain including headache and/or neck pain. If these events occur, they are usually temporary and subside within a few weeks of surgery.
- Rarely, cochlear implantation may cause a leak of the inner ear fluid, which may result in meningitis.
- During the surgery, it is a rare possibility that the facial nerve could be injured resulting in a temporary or permanent weakening or full paralysis on the same side of the face as the implant.

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- During the surgery, there is a rare possibility that cerebrospinal fluid leakage or perilymph fluid leakage could occur.
- As a result of the surgery, it is possible that dizziness, tinnitus, or vertigo may result. If these events occur, they are usually temporary and subside over time.
- The presence of a foreign body may cause irritation, inflammation, or skin breakdown and may require additional medical treatment or removal of the internal device.
- Skin infection in the area of the implant may require additional medical treatment or removal of the internal device.
- There is a possibility that the electrode or device may migrate requiring additional medical treatment or removal of the internal device to address any resulting injury.

## IX. SUMMARY OF NONCLINICAL STUDIES

The preclinical studies (bench and animal) that were previously submitted to FDA in the original PMA (P960058) and its supplements continue to support the safety and effectiveness of the commercially available HiResolution™ Bionic Ear System.

No additional preclinical studies were required to evaluate the performance of the HiResolution™ Bionic Ear System for the treatment of patient populations under the expanded indications for SSD/AHL. The previously approved supplements which support the device system and its components are listed below in Table 1.

Table 1: Summary of recent System / Device Components and Their Respective Approval References

| Device | Approval Reference |
| --- | --- |
| **Cochlear Implants:** | |
| HiRes™ Ultra CI HiFocus MS Electrode and HiRes™ Ultra CI HiFocus Slim J Electrode | P960058/S117 and S121 |
| HiRes™ Ultra 3D HiFocus MS Electrode and HiRes™ Ultra 3D CI HiFocus Slim J Electrode | P960058/S129 |
| **Sound Processors:** | |
| Naida CI Q series (Naida CI Q70, Q30 and Q90) | P960058/S102 and S114 |
| Naida CI M series (Naida CI M30, Naida CI M90, and Sky CI M90) | P960058/S149 |
| **Fitting Software:** | |
| Target CI | P960058/S149 |
| **Applications:** | |
| AB Remote | P960058/S149 |
| AB Remote Support | P960058/S159 |

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# X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant provided clinical performance data to establish a reasonable assurance of safety and effectiveness of expanding the approved indications with the HiResolution™ Bionics Ear System to include recipients with SSD/AHL in the US. Clinical data is presented from a prospectively designed, retrospective study conducted in accordance with the FDA guidance “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” The applicant also performed a supporting systematic literature review for both adult and pediatric patients.

A summary of the real-world evidence is presented below.

# A. Study Design

The purpose of this retrospective study (CR1022) was to gather real-world data (RWD) to demonstrate a reasonable assurance of the safety and effectiveness of cochlear implantation with the Advanced Bionics HiResolution™ Bionic Ear System in the worse ear for recipients with severe to profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss (i.e., AHL) or normal or near normal hearing in the contralateral ear (i.e., SSD).

This study used a retrospective, within-subject, repeated-measures design. A within-subject repeated-measures study design was considered appropriate as it accommodates the heterogeneity that characterizes hearing-impaired populations.

The study was designed as a multi-center study to provide a more representative sample of the target population and to support generalization of the study findings. Existing audiological outcomes and safety data obtained as a part of either routine clinical follow-up or previous research projects were extracted via a retrospective review of data sources such as billing or medical records, clinic or research databases, and commercial CI fitting software databases.

Device and procedure-related Adverse Events (AE) and Serious Adverse Events (SAE) were collected during the study as documented in medical records. Events were recorded and tracked between implantation and the last study visit.

# 1. Clinical Inclusion and Exclusion Criteria

Enrollment in the Retrospective Study of Advanced Bionics Recipient Outcomes with Single-Sided Deafness and Asymmetric Hearing Loss study was limited to patients who met the following inclusion criteria:

- Patients who received an AB CI (HiRes 90K, HiRes 90K Advantage, HiRes Ultra, HiRes Ultra 3D) in the year 2008 or later for the treatment of SSD or AHL.
- Aged 13 years or older at time of implantation.

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• Pre-op audiometric thresholds and speech perception scores:

○ Ear to be implanted:

▪ Severe to profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz ≥ 70 dB HL)
▪ Aided speech perception score (CNC) of ≤ 40%.

○ Contralateral Ear:

▪ SSD: Normal or near normal hearing (NH; 4PTA of 500, 1000, 2000, and 4000 Hz ≤ 30 dB HL).
▪ AHL: Up to moderately severe HL, i.e., a 4PTA >30 and ≤ 70 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz, with a difference of at least 15 dB in PTAs between ears.

• Minimum of six months of post-activation CI use experience
• Availability of CNC word scores in quiet at baseline (pre-surgery) and 1 year ± 6 months post-CI activation.

Patients were not permitted to enroll in the Retrospective Study of Advanced Bionics Recipient Outcomes with Single-Sided Deafness and Asymmetric Hearing Loss study if they met any of the following exclusion criteria:

• Clinical presentation indicative of potential implanted device malfunction at or within ± 6 months of CI activation.
• Unavailability of speech outcomes with validated tests in the English language.

# 2. Follow-up Schedule

Existing audiological outcomes and safety data obtained as a part of either routine clinical follow-up or previous research projects were extracted via a retrospective review of data sources such as billing or medical records, clinic or research databases, and commercial CI fitting software databases. Data from postoperative follow-up visits conducted approximately 1, 2, 3, 4, and 5 years after the baseline measurement were retrospectively collected and analyzed. There was no prospective data collection. Hence, no additional clinic visits were required by subjects.

# 3. Clinical Endpoints

Safety data were gathered from the currently approved indications for individuals with bilateral sensorineural hearing loss with the same device. Since unilateral implantation is not expected to differ from bilateral implantation in rate or severity of adverse events, a safety analysis of the current literature was conducted (see Section XI).

Effectiveness testing included speech perception in quiet using monosyllabic CNC words in the implanted ear at 1 year ± 6 months post-CI activation compared to baseline best-aided scores. Supporting data included speech perception in noise (AzBio and HINT sentences), sound source localization accuracy (RMS error), and subjective ratings obtained with the Speech, Spatial and Qualities of Hearing Scale (SSQ) and Tinnitus

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Handicap Inventory (THI), each compared to baseline. Unaided air conduction thresholds in the non-implanted ear and average daily CI sound processor usage were also collected. Supporting data were collected through 5 years ± 6 months post-CI activation where available.

# Primary Effectiveness Endpoint

- Improvement in speech perception scores in quiet obtained with the implanted-ear-only at 1 year ± 6 months post-CI activation compared to the best-aided pre-operative scores. Scores were obtained with monosyllabic CNC words using one of the two methodologies: 1) From the front loudspeaker in the sound booth at 50 dB HL or 60 dBA with the better ear masked with speech-shaped noise at a level ranging from 50 to 75 dB HL and/or plugged and/or muffed and, 2) Using direct audio input to the CI sound processor.

The pre-specified null and alternative hypothesis are as follows:

H₀: For participants with SSD/AHL, change in mean word recognition scores from pre-operation to 1-year (+ 6 months) post-CI activation is less than or equal to 10 percentage points.

μPOST - μPRE ≤ 10%

Hₐ: For participants with SSD/AHL, change in mean word recognition scores from pre-operation to 1-year (+ 6 months) post-CI activation is greater than 10 percentage points.

μPOST - μPRE >10%

At the individual level, a change of >10% was considered clinically meaningful (Firszt et al., 2023). Although the primary endpoint comparison was between pre-operative scores and 1-year post-CI activation (± 6 months) scores, available data up to 5 years post-CI activation (± 6 months) were also extracted. The change in CNC scores from 1 year ± 6 months to 5 years ± 6 months post-CI activation was evaluated by examining the slope over that time span using a linear mixed model. Separate analyses were conducted for the AHL and SSD cohorts. A nonlinear trend was expected, with a change from baseline to 1 year ± 6 months, but relatively flat at later time points.

Two analysis populations were used: the Intent-to-Treat (ITT) population, which included all eligible enrolled subjects with imputed values where needed and served as the primary population for the safety and effectiveness analyses. The Modified ITT (mITT) population, which included only subjects with measured (non-imputed) data and served as the primary population for supporting data analyses.

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Where a baseline CNC score was not measured, an “assumed 0” score was recorded consistent with common clinical practice for profoundly impaired ears. To avoid inflating the magnitude of post-implant improvement, multiple imputation (Little and Rubin, 2002) was applied using available baseline audiological and demographic variables.

### Secondary Effectiveness Endpoints

- Pre-operative (baseline) best-aided speech in noise scores with AzBio and HINT sentences at fixed SNR in the \( S_{0}N_{0} \) and \( S_{0}N_{BE} \) speaker configurations were compared to those obtained at 1 year ( \( \pm \) 6 months) post-CI activation with the everyday listening configuration. The pre-specified null and alternative hypotheses are as follows:

\( H_{0} \) : For participants with SSD/AHL, change in mean of the percent correct speech perception scores from pre-operation to 1-year ( \( \pm \) 6 months) post-CI activation are equivalent is less than or equal to 10%.

\[
\mu P O S T - \mu P R E \leq 10 \%
\]

\( H_{A} \) : For participants with SSD/AHL, change in mean of the percent correct speech perception scores from pre-operation to 1-year ( \( \pm \) 6 months) post-CI activation is greater than 10%.

\[
\mu P O S T - \mu P R E > 10 \%
\]

At an individual level, a change of \( >10\% \) was considered clinically meaningful based on the 95% confidence intervals reported by Spahr et al. (2012).

- Sound source localization accuracy at 1 year (±6 months) post-CI activation with everyday listening configuration (both ears) was compared to pre-operative performance. Localization accuracy was measured using a multi-speaker array in the horizontal plane via one of two methodologies: A) sixteen different everyday sounds presented randomly at 60 dB SPL from one of eight speakers arranged in a 108-degree horizontal arc (Hansen et al., 2013; Sullivan et al., 2020) and, B) monosyllabic words presented randomly at 60 dB SPL from one of 15 speakers arranged in a 140-degrees horizontal arc (Firszt et al., 2018). In both methods, listeners were asked to identify the speaker from which the sound was presented.

The pre-specified null and alternative hypotheses are as follows:

H0: For participants with SSD/AHL, change in mean RMS error from pre-operation to 1 year ( \( \pm \) 6 months) post-CI activation is greater than or equal to \( -6^{\circ} \) .

\[
\mu P O S T - \mu P R E \geq - 6 ^ {\circ}
\]

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H$_{A}$: For participants with SSD/AHL, change in mean RMS error from pre-operation to 1-year (± 6 months) post-CI activation is less -6°.

$$\mu POST - \mu PRE < -6^{\circ}$$

At an individual level, a change of ≥ -6° was considered a meaningful change. Localization abilities have been widely studied and found to differ greatly across listeners based on hearing loss severity, as well as the listener's hearing technology, and hearing device configuration. The 6° margin was selected based on a medium effect size (0.5 × 12° SD; Leppink et al., 2016), consistent with published RMS error variability in bilateral CI and SSD populations (Jones et al., 2014; Dorman et al., 2016).

- Subjective ratings obtained with the SSQ at 1 year (± 6 months) post-CI activation were compared to that measured pre-operatively. The pre-specified null and alternative hypotheses are as follows:

H$_{0}$: For participants with SSD/AHL, change in mean SSQ ratings from pre-operation to 1 year (± 6 months) post-CI activation is less than or equal to 1.

$$\mu POST - \mu PRE \leq 1$$

H$_{A}$: For participants with SSD/AHL, change in mean SSQ ratings from pre-operation to 1 year (± 6 months) post-CI activation is greater than 1.

$$\mu POST - \mu PRE > 1$$

At the individual level, a change of >1 was considered a clinically meaningful change as reported by Wick et al. (2020) and Cowan et al. (2024).

These data were collected up to 5 years (± 6 months) post-CI activation and reported to document longer-term effectiveness. The change in outcomes from 1 year (± 6 months) to 5 years (± 6months) post-CI activation was evaluated by examining the slope over that time span using a linear mixed model.

### B. Accountability of PMA Cohort

Six USA study sites enrolled a total of 91 subjects implanted with a HiResolution™ Bionic Ear System (HiRes 90K and newer), with surgeries occurring between February 2002 and September 2023. Prior to data extraction, Institutional Review Board (IRB) approval and HIPAA waivers were obtained at all participating sites. Of the 91 subjects, 19 screen failed; five of these were retained in the ITT population due to missing baseline and/or 1-year CNC scores.

Of the remaining 72 subjects, 25 were enrolled in the SSD cohort and 47 were enrolled in the AHL cohort and form the primary analysis population. Fifty-two of

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the 72 subjects were noted to have “completed the study,” because they either had a data point available at the 5 years ± 6 months visit interval or were still under clinical care at the time of data extraction. Twenty subjects were classified as discontinued following the 1-year visit due to lost to follow-up or CI revision surgery; their available data were included in the analysis. The label “discontinued” indicates that they had either been lost to clinical follow-up or were in the process of getting a CI revision surgery after the 1-year (± 6 months) visit. Data were available from 72, 35, 25, 15, and 16 subjects at the 1-, 2-, 3-, 4-, and 5-year ± 6 months intervals, respectively.

### C. Study Population Demographics and Baseline Parameters

The ITT population consists of 77 subjects (28 SSD and 49 AHL). Of the 77 ITT subjects, 64 subjects (19 SSD and 45 AHL) were included in the mITT population, which consists of subjects from the ITT population with available measured data.

Of the 72 subjects enrolled who met eligibility criteria, 37 subjects (12 SSD and 25 AHL) were female, and 35 subjects (13 SSD and 22 AHL) were male. All subjects were over 18 years of age at the time of implantation. In the SSD cohort, age at the time of implantation ranged from 25.72 years to 76.9 years with a mean of 53.08 years. In the AHL cohort, subject age at the time of implantation ranged from 18.33 years to 85.72 years, with a mean of 61.3 years.

CNC word scores in quiet were available for all 72 enrolled subjects. Availability of supporting data (speech in noise, SSQ, THI) varied across subjects and time points, as expected in a retrospective study. Supporting data were included when available at baseline and at least one follow-up interval, with the additional requirement that speech in noise scores were obtained under the same noise type and signal-to-noise ratio (SNR) at both visits.

### D. Safety and Effectiveness Results

#### 1. Safety Results

The safety analysis was based on the 72 subjects described above, with data from 52 subjects available for the 5-year 6-month evaluation.

Adverse events were collected during the study as documented in the data sources, and these events were recorded and tracked from the time of implantation until the last study visit date. In total, 78 AEs were documented, with five of these being classified as SAEs. For the identified SAEs, four were due to hospitalization or prolongation of hospitalization, and one required intervention to prevent impairment. The remaining AEs were anticipated risks of this device and/or procedure. No unanticipated AEs or serious procedure-related AEs were reported during the study. The frequency and type of AEs did not reveal unexpected safety concerns.

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## 2. Primary Effectiveness Results

The primary effectiveness endpoint for SSD/AHL CI recipients was the comparison of monosyllabic (CNC) word scores obtained in quiet in the implanted ear only at 1 year ± 6 months post-CI activation with baseline best-aided CNC scores.

# **SSD Cohort:**

Outcomes were first analyzed for 19 subjects who had a best-aided CNC score available at baseline and for the combined group of 28 to include the 9 subjects with “assumed 0” scores at baseline or missing CNC scores at 1 year.

In the group with measured baseline CNC scores (N=19), mean scores at 1 year ± 6 months were greater than those at baseline by 32.32% (22.22 SD, 95% CI: 21.61 to 43.02, p=0.0002). Fifteen of 19 subjects (78.9%) demonstrated a clinically meaningful improvement of ≥10%.

In the combined analysis (n=28), imputed scores were used as baseline CNC scores for the six subjects with “assumed 0” baseline CNC scores, and imputed scores were used as CNC scores at 1 year for the three subjects missing CNC scores at 1 year. Mean CNC scores at 1 year ± 6 months were greater than those at baseline by 35.7% (26.72 SD, 95% CI: 25.34 to 46.06, p < 0.0001). Twenty-two of 28 subjects (78.6%) demonstrated a clinically meaningful improvement of ≥10%.

# **AHL Cohort:**

Outcomes were analyzed first for 45 subjects who had a best-aided CNC score available at baseline and then for the combined group of 49 that included the four subjects with “assumed 0” scores at baseline or missing CNC scores at 1 year.

In the group with measured baseline CNC scores, mean improvement in scores at 1 year ± 6 months was 36.22% (28.62 SD, 95% CI: 27.62 to 44.82, p < 0.0001). Thirty-six of 45 subjects (80%) showed a clinically meaningful improvement of ≥ 10%.

As with the SSD cohort, imputed scores were used as baseline CNC scores for the two subjects with “assumed 0” baseline CNC scores, and imputed scores were used as CNC scores at 1 year for the two subjects with missing CNC scores at 1 year in the combined analysis for the AHL cohort. Across the 49 subjects, mean change at 1 year ± 6 months as compared to baseline was 34.05% (28.85 SD, 95% CI: 25.76 to 42.34, p < 0.0001). Thirty-eight of 49 subjects (77.6%) demonstrated a clinically meaningful improvement of ≥ 10%.

# **Long-Term Effectiveness:**

SSD subjects (n=28): At follow-up intervals of 2 years, 3 years, 4 years, and 5 years (± 6 months), the following percentages of subjects showed a ≥10% improvement in CNC scores from baseline: 81.8% (9/11), 90.9% (10/11), 100% (5/5), and 100% (5/5),

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respectively. The change from baseline was statistically significant through the 3 years ± 6 month time point. Linear mixed model analysis resulted in a slope of 0.427 (p=0.8050), indicating that the scores remained stable out to 5 years ± 6 months.

AHL subjects (N=49): At follow-up intervals of 2 years, 3 years, 4 years, and 5 years (± 6 months), the following percentages of subjects showed a ≥10% improvement in CNC scores from baseline: 87% (20/23), 76.9% (10/13), 87.5% (7/8), and 100% (8/8), respectively. The change from baseline was statistically significant at all follow-up intervals. Linear mixed model analysis resulted in a slope of 4.314 (p=0.0031), indicating an improvement in scores out to 5 years ± 6 months.

## Effectiveness in Adults with Baseline CNC Scores of 6-20%

To support the adult speech criterion of ≤20% CNC words, effectiveness was assessed across three baseline CNC subgroups in the ear to be implanted: (i) ≤5%, (ii) >5 to ≤20%, and (iii) >20 to ≤40%. The pre-specified threshold for success was >50% of subjects achieving a clinically meaningful improvement of ≥10%. This threshold was met in subgroups (i) and (ii) in both cohorts, supporting the expanded candidacy criterion up to a baseline CNC score of 20%.

- SSD: 87% (13/15) in the ≤5% group; 100% (6/6) in the >5–≤20% group; 50% (2/4) in the >20–≤40% group.
- AHL: 85% (23/27) in the ≤5% group; 71% (10/14) in the >5–≤20% group; 50%(3/6) in the >20–≤40% group

| **Table 2: Pooled CNC In Quiet Data (Measured With Best Aided CI Ear) mITT Adult Subjects With Baseline CNC Scores From 6-20%** | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | **Baseline** | **1Y +/- 6mo** | **2Y +/- 6mo** | **3Y +/- 6mo** | **4Y +/- 6mo** | **5Y +/- 6mo** |
| **SSD Cohort** | | | | | | |
| Mean ± SD (N) | 9.75 ± 3.50 (4) | 41.25 ± 16.28 (4) | 42.50 ± 2.12 (2) | 68.00 ± 0.00 (1) | 26.00 ± 0.00 (1) | |
| Median (Min, Max) | 9.50 (6.00, 14.00) | 40.50 (24.00, 60.00) | 42.50 (41.00, 44.00) | 68.00 (68.00, 68.00) | 26.00 (26.00, 26.00) | |
| **Post-op data comparison with baseline data** | | | | | | |
| N | | 4 | 2 | 1 | 1 | |
| N (%) achieving ≥ 10% | | 4 (100.0%) | 2 (100.0%) | 1 (100.0%) | 1 (100.0%) | |

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Table 2: Pooled CNC In Quiet Data (Measured With Best Aided CI Ear)
mITT Adult Subjects With Baseline CNC Scores From 6-20%

| | Baseline | 1Y +/- 6mo | 2Y +/- 6mo | 3Y +/- 6mo | 4Y +/- 6mo | 5Y +/- 6mo |
| --- | --- | --- | --- | --- | --- | --- |
| Mean (SD) | | 31.50 (12.79) | 33.00 (4.24) | 60.00 | 18.00 | |
| (95% CI) | | (11.14, 51.86) | (-5.12, 71.12) | | | |
| t-statistics | | 3.36 | 7.67 | | | |
| Degrees of freedom | | 3 | 1 | | | |
| One sided p- value | | 0.0218 | 0.0413 | | | |
| Linear mixed model assessment of change after 1Y +/- 6mo | | | | | | |
| Slope | | -0.225 | | | | |
| SE | | 4.697 | | | | |
| p-value | | 0.9633 | | | | |
| AHL Cohort | | | | | | |
| Mean ± SD (N) | 13.58 ± 4.93 (12) | 49.00 ± 25.66 (12) | 66.40 ± 11.78 (5) | 83.00 ± 10.82 (3) | 63.33 ± 6.11 (3) | 66.00 ± 19.08 (3) |
| Median (Min, Max) | 15.00 (6.00, 20.00) | 50.00 (8.00, 92.00) | 60.00 (56.00, 82.00) | 80.00 (74.00, 95.00) | 62.00 (58.00, 70.00) | 76.00 (44.00, 78.00) |
| Post-op data comparison with baseline data | | | | | | |
| N | | 12 | 5 | 3 | 3 | 3 |
| N (%) achieving ≥ 10% | | 10 (83.3%) | 5 (100.0%) | 3 (100.0%) | 3 (100.0%) | 3 (100.0%) |
| Mean (SD) | | 35.42 (26.47) | 52.00 (12.08) | 68.33 (12.74) | 46.67 (4.62) | 49.33 (20.23) |
| (95% CI) | | (18.60, 52.24) | (37.00, 67.00) | (36.68, 99.98) | (35.19, 58.14) | (-0.93, 99.59) |
| t-statistics | | 3.33 | 7.77 | 7.93 | 13.75 | 3.37 |

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Table 2: Pooled CNC In Quiet Data (Measured With Best Aided CI Ear) mITT Adult Subjects With Baseline CNC Scores From 6-20%

| | Baseline | 1Y +/- 6mo | 2Y +/- 6mo | 3Y +/- 6mo | 4Y +/- 6mo | 5Y +/- 6mo |
| --- | --- | --- | --- | --- | --- | --- |
| Degrees of freedom | | 11 | 4 | 2 | 2 | 2 |
| One sided p-value | | 0.0034 | 0.0007 | 0.0078 | 0.0026 | 0.0390 |

Linear mixed model assessment of change after 1Y +/- 6mo

| Slope | | 4.451 | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| SE | | 2.369 | | | | |
| p-value | | 0.0725 | | | | |

Note 1: Table does not include screen failures.

Note 2: Table only includes subjects with measured CNC scores at baseline.

Note 3: Table does not include subjects who do not have data at Baseline and at a minimum One Year visit.

Note 4: One-sided p-value based on the paired t-test, testing the null hypothesis: H₀: μₚₒₛₜ - μₚᵣₑ <= 10%, where μₚᵣₑ represents the mean word recognition scores in quiet at baseline, and μₚₒₛₜ represents the mean word recognition scores in quiet at 1- year post CI activation.

Among adult subjects with baseline CNC scores in the 6–20% range, clinically meaningful improvement of ≥10% was achieved in 100% of SSD subjects (6/6) and 71% of AHL subjects (10/14), exceeding the pre-specified >50% responder threshold in both cohorts. Across both groups combined, 16 of 20 subjects (80%) with baseline scores in this range demonstrated clinically meaningful benefit, supporting the expanded adult speech criterion of ≤20%. Speech perception in noise data for this subgroup were limited due to small sample sizes, particularly in the SSD cohort, and are therefore not presented in tabular form. Available AHL data showed clinically meaningful improvement (>10%) in the majority of subjects with data at most intervals through 5 years, though these results should be interpreted with caution given the limited sample sizes.

### 3. Secondary Effectiveness Results

#### Speech Perception Scores In Noise

Speech perception in noise data were limited across both cohorts and should be interpreted with caution. In the SSD cohort, six subjects had S₀N₀ data at 1 year ± 6 months; the mean change of 15.3% was clinically meaningful but did not reach statistical significance (p=0.31), likely reflecting insufficient sample size. S0NBE data were available for only four subjects, with a mean change of 4.1% at 1 year (p=0.99).

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In the AHL cohort, 20 subjects had S₀N₀ data at 1 year ± 6 months; the mean change of 21.1% was clinically meaningful with 60% of subjects showing >10% improvement, though statistical significance was not reached (p=0.057). The majority of subjects with available data at 2-, 3-, 4-, and 5-year intervals continued to show >10% improvement. S₀NBE data were available for only one subject, who showed a 62% and 44% improvement at 1 and 3 years, respectively.

## Sound Source Localization Accuracy

Localization data were available from two sites using different methodologies (Method A: 8-speaker 108° arc; Method B: 15-speaker 140° arc) and were analyzed by methodology where within-subject comparisons were possible.
In the SSD cohort, combined data from both methods were available for 6 subjects at baseline and 1 year ± 6 months. Mean RMS error improved from 41.5° to 27.0° (mean improvement 14.5°, p=0.17); the null hypothesis could not be rejected. Half of subjects (3/6) achieved the >6° individual threshold at 1 year, with limited longer-term data available.

In the AHL cohort, combined data were available for 12 subjects at baseline and 1 year ± 6 months. Mean RMS error improved from 43.4° to 29.4° (mean improvement 14.0°, p=0.033); the null hypothesis could not be rejected as the improvement did not significantly exceed the -6° threshold. The majority of subjects with available data showed a >6° improvement at each follow-up interval: 75% (9/12) at 1 year, 86% (6/7) at 2 years, and 100% at 3 and 4 years.

## Speech, Spatial And Qualities Of Hearing Scale (SSQ)

In the SSD cohort, SSQ data were available from seven subjects. Statistically significant improvements from baseline to 1 year ± 6 months were observed across all subscales and the global score (speech: +3.3, p=0.003; spatial: +4.3, p=0.005; qualities: +1.8, p=0.036; global: +3.1, p=0.004), rejecting the null hypothesis for the global score. All subjects with available data reported improved ratings on the speech and spatial subscales; 71% showed improvement on the qualities subscale. Limited 2-year data (n=3) showed sustained improvement across all subscales.

In the AHL cohort, SSQ data were available from 12 subjects. Statistically significant improvements from baseline to 1 year ± 6 months were observed across all subscales and the global score (speech: +3.1, p=0.005; spatial: +3.5, p=0.0003; qualities: +2.5, p=0.003; global: +3.0, p=0.001), rejecting the null hypothesis for the global score. At least 75% of subjects showed a clinically meaningful improvement of >1 on each subscale at 1 year, with all subjects showing continued improvement at 2- and 3-year intervals where data were available.

## Tinnitus Handicap Inventory (THI)

In the SSD cohort, data were available from two subjects at baseline and 1 year ± 6

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months, and the mean ratings dropped from 44 (5.66 SD) to 5 (7.07 SD). The mean change was 39 (12.73 SD) with both subjects reporting a change in degree of perceived tinnitus from moderate to slight. In the AHL cohort, data were available from only one subject at baseline and 1 year ± 6 months, where the rating dropped from 16 to 0.

# 4. Subgroup / Covariate Analyses

Subgroup analyses of the primary effectiveness endpoint were performed across the following variables: duration of hearing loss, implant type, sex, age at implantation, baseline 4PTA, baseline best-aided CNC score, duration of severe-to-profound hearing loss, and timing of onset. Subgroup analyses were not performed for speech in noise due to limited available data.

In the AHL cohort, potential lack of homogeneity was observed for duration of hearing loss (p=0.002), implant type (p=0.052), baseline 4PTA (p=0.006), and baseline best-aided CNC score (p=0.128). Subjects with longer duration of hearing loss showed greater mean improvement (55.4% vs. 26.5% for ≥ vs. < median duration). Subjects with higher baseline 4PTA showed greater improvement (47.5% vs. 24.5% for ≥ vs. < median PTA), as did those with poorer baseline CNC scores (43.2% vs. 30.1% for < vs. ≥ median CNC). Mean paired differences across implant types ranged from 28.5% to 58.3%. No evidence of heterogeneity was observed for sex, age, duration of severe-to-profound hearing loss, or timing of onset.

In the SSD cohort, potential lack of homogeneity was observed only for baseline best-aided CNC score (p=0.098), with subjects below the median showing greater improvement (41.2% vs. 24.3%). No evidence of heterogeneity was observed for the remaining variables, suggesting consistent benefit regardless of baseline characteristics.

Continuous covariates were assessed with linear regression and categorical covariates with an ANOVA, with change in CNC word scores from baseline to 1 year ± 6 months as the outcome variable. In the AHL cohort, duration of hearing loss was positively associated with improvement (slope=0.76, 95% CI: 0.15–1.35; p=0.015) and baseline CNC score was negatively associated with improvement (slope=-0.90, 95% CI: -1.63 to -0.18; p=0.015), consistent with the subgroup findings above. No statistically significant covariate relationships were identified in the SSD cohort. Covariate analyses were not performed for speech in noise due to limited data availability.

# Stratified Analysis for Co-Primary Endpoints

Stratified performance analyses were conducted for CNC words in quiet; speech-in-noise data were insufficient for stratified analysis. Better, similar, and poorer performance were defined as a change of >10%, -10% to 10%, and <-10% from baseline, respectively. In the SSD cohort (N=19), 79% of subjects demonstrated better

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performance, 21% similar, and none poorer. In the AHL cohort (N=45), 80% demonstrated better performance, 16% similar, and 4% poorer.

# Discussion of Results

The primary effectiveness endpoint was met in both cohorts, with clinically significant improvements in CNC word scores in the implanted ear at 1 year ± 6 months post-CI activation. Mean improvement was 35.7% in the SSD cohort (p<0.0001) and 34.1% in the AHL cohort (p<0.0001), with approximately 79% and 78% of subjects, respectively, achieving the ≥10% clinically meaningful threshold. Improvement was sustained 5 years ± 6 months in both cohorts (for a subset of subjects with available data at this time point).

Secondary effectiveness endpoints demonstrated that speech perception in noise scores showed clinically significant mean improvements in both cohorts at 1 year, though statistical significance was not reached (potentially due to insufficient sample size). Localization accuracy improved in the majority of subjects in both cohorts at 1 year. SSQ global scores improved in both cohorts at 1 year, with improvements sustained through available longer-term follow-up. Audiometric thresholds in the non-implanted ear remained stable within test-retest reliability limits through 3–4 years post-activation.

Subgroup analyses identified that subjects with poorer baseline CNC scores and, in the AHL cohort, longer duration of hearing loss and higher baseline 4PTA, tended to show greater improvement, which is consistent with outcomes in bilateral CI literature. Importantly, clinically significant improvement was demonstrated in subjects with baseline CNC scores up to 20% in the ear to be implanted, supporting the expanded adult audiometric speech criterion.

# 5. Pediatric Extrapolation

In this premarket application, existing clinical data was leveraged to support the reasonable assurance of safety and effectiveness of the HiResolution™ Bionics Ear System in children 5 years and older with SSD or AHL.

Advanced Bionics used the Pediatric Extrapolation Decision Tree provided in the FDA guidance Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices to determine whether a full or partial extrapolation of the existing data from studies with adult participants would be appropriate for this submission.

# Pediatric Extrapolation Decision Tree

# Question A: Does the treated disease or condition occur in a pediatric (sub)population(s)?

Yes. Unilateral profound sensorineural hearing loss occurs in the pediatric population as well as in adults. In the US, the overall prevalence of unilateral hearing loss (UHL) in adults has been reported to be 7.2% (95% confidence interval 6.1%-8.6%), with

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1.5% (0.1%-2.1%) with moderate-or-worse UHL (Golub et al, 2018). More recently, Kay-Rivest et al (2022) estimated the prevalence of SSD in adults in the US to be 0.14% (95% CI=0.08-.024).

In infants, the incidence of UHL is reported to be 1/1000 live births in the US (Lieu et al, 2018). In the 2022 annual data report of the Early Hearing Detection and Intervention (EHDI), the US Centers for Disease Control and Prevention (US CDC, 2024) reported that 6,272 infants born between January 1, 2022 and December 31, 2022 were diagnosed with hearing loss. Of these, 593 infants had a mild to severe unilateral sensorineural hearing loss and 289 infants had a unilateral profound sensorineural hearing loss. Further, 113 infants were reported to have a mild to severe UHL and 25 had a profound UHL of unknown type. Estimates of prevalence of AHL are typically more difficult to estimate as these individuals are often combined with those with bilateral symmetric hearing loss.

By ages 6 to 9 years, the prevalence of UHL is reported to be higher at approximately 3% to 6.3% (Lieu et al, 2018; Ross et al, 2010; Shargorodsky et al, 2010). Boyd (2015) estimated that of the children with HL, the proportion of those with severe to profound UHL may be around 30-50%.

Thus, the treated condition occurs in the pediatric population.

### Question B: Is there an endpoint present in the existing data source that measures device effects relevant to the intended pediatric (sub)population(s)?

Yes. Monosyllabic word recognition tasks (CNC) were used to measure efficacy in the AB adult retrospective SSD/AHL study. Similar speech perception measures are typically used with children, depending on their age. While individual variability exists, children are generally capable of completing monosyllabic word recognition tasks, exhibiting results similar to adult datasets by the age of 4-5 years (Uhler et al., 2017). For children under 5 years of age there is significant uncertainty when obtaining ear-specific hearing information, particularly related to speech perception. Therefore, data extrapolation is not currently considered suitable for children under 5 years of age. Supporting data in the AB adult retrospective study included comparisons of pre- and post-CI surgery subjective ratings obtained with a validated questionnaire (SSQ), speech perception in noise scores, and sound source localization accuracy. All these measures are relevant to the intended pediatric population as children spend 80% of their time in speech-in-noise situations (Crukley, Scollie & Parsa, 2011). In addition, average daily device use was evaluated through sound processor datalogs. The literature also shows multiple studies where children with CIs were evaluated with the same measures as in the AB adult retrospective study. For example, Benchetrit et al (2021) performed meta-analyses on 119 children with SSD. They found CIs to provide clinically meaningful improvements in most children for speech perception in quiet and in noise, and sound localization and significantly improved subjective hearing outcomes measured by the SSQ.

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Arndt et al (2024) utilized measures of speech perception in quiet and in noise, localization and SSQ to retrospectively evaluate outcomes in 36 children with SSD. Cadieux et al (2013) evaluated five adolescents with AHL with tests of speech recognition in quiet (CNCs) and in noise and localization. Examples of average daily device use duration measured with sound processor datalogs in SSD children include Arndt et al (2024), Deep et al (2021a) and Polonenko et al (2017). Therefore, the endpoints used in the existing adult data (CNC, speech perception in noise, sound localization, SSQ and device use logs) are relevant to the intended pediatric population. The relevance of these endpoints is further detailed in a literature review in section 3 below.

### Question C: Expected similarity of response to intervention

Question C-1: Is the device implanted or in contact with the body, and if so, does either the location or duration of the implantation differ between the adult and intended pediatric (sub)population(s) in such a way that either the safety or effectiveness of the device could be impacted in a clinically meaningful way?

No. The HiResolution™ Bionic Ear System is comprised of external components (sound processor, cable, head/earpiece) and internal components (cochlear stimulator and electrode). The system is identical for adults and children. The location and the duration of implantation of the internal components is not different between children and adults. The HiResolution™ Bionic Ear System is already approved for pediatric subpopulations of ages 12 months and older with bilateral profound sensorineural hearing loss. To date, over 11,000 pediatric CI recipients have been implanted with AB devices in the US with a well-established benefit/risk profile. The intended location and the duration of implantation of the internal components for children with SSD or AHL is the same as what is already in on-label use with adults as well as children ages 12 months and older with bilateral profound hearing loss. This supplement seeks approval for an expanded indication but does not change the surgical procedure for the device.

Question C-2: Are there differences in the device characteristics between pediatric and adult use that could impact either device safety or effectiveness in the pediatric (sub)population(s) in a clinically meaningful way?

No. As stated above, the HiResolution™ Bionic Ear system used by both adults and children is the same and is currently in on-label use for individuals 12 months and older. The mechanism of action of the internal components of the implant is similar in both populations. The nature of reported adverse events is no different than that observed in CI recipients implanted under currently approved indications.

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There may be differences in how clinicians program noise management settings in younger children. However, this clinical scenario is no different than that for children who meet current approved AB indications. Program settings are intended to be adjusted by healthcare professionals to suit individual CI recipients. These differences in device characteristics are considered minor and are not expected to impact safety or effectiveness.

# **Question C-3: Are there characteristics unique to the intended pediatric (sub)population(s) that could impact either device safety or effectiveness in the pediatric (sub)population(s) in a clinically meaningful way?**

No. The benefit-risk profile for this population, already established in children with bilateral profound hearing loss, is not expected to change for children and adolescents with SSD and AHL where only the ear with profound sensorineural hearing loss is to be implanted. Existing literature shows that a majority of children and adults show improved outcomes post implantation, especially those with acquired UHL. For children who present with AHL or SSD, only the affected ear is implanted. Since the non-implanted ear remains intact, evaluation of auditory benefit can be determined in this pediatric population. By age 5 years language should be developed, so this age group can be evaluated and treated similarly to adults.

# **Question C-4: Are there differences in disease characteristics between adult and pediatric (sub)population(s) that could impact either device safety or effectiveness in the pediatric (sub)population(s) in a clinically meaningful way?**

No. There are no differences in the fundamental characteristics of profound sensorineural hearing loss between adult and pediatric populations that would impact device safety or effectiveness. Adult and pediatric patients with severe and/or profound sensorineural hearing loss are treated with the same CI systems and full electrode insertions are feasible in both populations with typical cochlear anatomies.

# **Question C-5: Are there any other differences between adult and pediatric (sub)population(s) that could impact either device safety or effectiveness in the pediatric (sub)population(s) in a clinically meaningful way?**

No. There are no additional differences between the two populations that could impact either device safety or effectiveness in children in a clinically meaningful way. The safety profile of cochlear implantation has been well-established and confirmed in pediatric populations aged 12 months and older with bilateral, profound, sensorineural hearing loss. Effectiveness in the adult AHL/SSD population has been established in the Advanced Bionics retrospective study demonstrating statistically significant improvement in quiet both groups (SSD: mean change= 35.2%, 24.28 SD, p<0.0001; AHL: mean change= 34.35%, 29.43

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SD, p<0.0001). A clinically meaningful improvement of >10% from baseline was observed in 80% of the subjects in the SSD cohort and 76.6% of the subjects in the AHL cohort. The improvement persisted long term (out to 5 years ± 6 months, the maximum study duration.) In both the AHL and SSD cohort, SSQ ratings (global as well as for the speech and spatial subscales) improved significantly from baseline at 1 year ± 6 months post-CI activation, thereby suggesting improved hearing outcomes in everyday situations. Average daily device use was stable out to 5 years ± 6 months post-CI activation, with annual daily averages ranging between 7.82 to 9.2 hours/day in the SSD cohort and 8.47 to 9.77 hours/day in the AHL cohort. Adverse events were collected during the study as documented in the data sources, and these events were recorded and tracked from the time of implantation until the last study visit date. In total, 78 AEs were documented, with five of these being classified as SAEs. Of the events noted as SAEs, four were classified as such due to hospitalization or prolongation of hospitalization, and one required intervention to prevent impairment. The frequency and type of adverse events did not reveal unexpected safety concerns.

## Overall Conclusions

Analysis of retrospective data from 72 subjects (25 SSD and 47 AHL) who received a CI in the worse ear demonstrated that the majority of subjects experienced clinically significant benefit following implantation.

The primary effectiveness endpoint was met in both cohorts, with mean CNC word scores in the implanted ear improving by 35.7% in the SSD cohort and 34.1% in the AHL cohort at 1 year ± 6 months post-activation (both p<0.0001). Approximately 79% of SSD subjects and 78% of AHL subjects achieved the pre-specified clinically meaningful threshold of ≥10% improvement. Clinically significant improvement was demonstrated in adult subjects with baseline CNC scores up to 20% in the ear to be implanted, supporting the expanded adult audiometric speech criterion. Speech perception in noise and sound localization trended toward improvement in both cohorts, though statistical significance was not reached, likely reflecting the limited sample sizes available for these measures. SSQ global scores improved significantly in both cohorts at 1 year, with improvements sustained through available longer-term follow-up.

In conclusion, the outcomes of this real-world retrospective analysis provide valid clinical evidence that cochlear implantation with the HiResolution™ Bionic Ear System in individuals with SSD or AHL is a safe and effective treatment option, with large, consistent, and durable benefit across speech perception, spatial hearing, and quality of life. Full extrapolation of these adult data to pediatric patients aged 5 years and older is supported by the consistency of the device, surgical procedure, and disease characteristics across populations. No prospective clinical data in the pediatric population were provided in this submission. Data extrapolation is not considered suitable for children under 5

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years of age, given the significant uncertainty in obtaining reliable ear-specific hearing information in this age group, consistent with the age indication for the bone anchored hearing aid (BAHA) for the same patient population.

## Clinical Study Data Limitations

The primary clinical evidence supporting this approval is derived from a prospectively designed retrospective analysis of RWD collected from 72 subjects across six US sites. The relevance and reliability of the RWD were evaluated in accordance with FDA RWE guidance and were determined to be of sufficient quality to support the proposed indication expansion. However, several limitations are noted. The sample size is relatively small, particularly at longer-term follow-up intervals where available data are limited. The study enrolled primarily adults, and pediatric extrapolation was leveraged to support the pediatric indication. Data were collected retrospectively, and statistical results are based on post-hoc analyses that may be subject to unidentified bias.

### E. Financial Disclosure

The Financial Disclosure by Clinical Investigators regulation (21 CFR 54) requires applicants who submit a marketing application to include certain information concerning the compensation to, and financial interests and arrangement of, any clinical investigator conducting clinical studies covered by the regulation. The pivotal clinical study included six investigators. None of the clinical investigators had disclosable financial interests/arrangements as defined in sections 54.2(a), (b), (c), and (f). The information provided does not raise any questions about the reliability of the data.

## XI. SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION

A literature review was performed on UHL, performed on 29th Jul 2024. The goal of this review was to assess speech perception in quiet and in noise as well as sound localization outcomes of subjects with SSD or AHL implanted with a CI.

### A. Literature Search Strategy

The search terms and inclusion and exclusion criteria are listed in Table 3 and 4 below, respectively.

Table 3: Combinations of Search Terms Used

| General Search Terms | Search Strings |
| --- | --- |
| Cochlear implant Single-sided deafness (SSD) Asymmetric hearing loss (AHL) Comparator devices Subject devices | PubMed (("cochlear implants"[MeSH Terms] OR "cochlear implantation"[MeSH Terms]) AND ("single-sided deafness"[All Fields] OR "single-sided deafness"[All Fields] OR "unilateral deafness"[All Fields] OR "unilaterally deaf"[All Fields] OR |

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| General Search Terms | Search Strings |
| --- | --- |
| | "asymmetric deafness"[All Fields]) AND "deaf"[All Fields] AND ("single-sided hearing loss"[All Fields] OR "single-sided hearing loss"[All Fields] OR "unilateral hearing loss"[All Fields] OR "asymmetric hearing loss"[All Fields]) AND ("nucleus"[All Fields] OR "Kanso"[All Fields]) AND ("cochlea"[MeSH Terms] OR "cochlea"[All Fields] OR "cochlear"[All Fields])) OR ("Med-el"[All Fields] OR "MEDEL"[All Fields] OR "Medical electronics"[All Fields]) OR "Oticon"[All Fields] OR "Advanced Bionics"[All Fields]) AND "cochlea*"[All Fields] AND 2020/01/01:2025/12/31[Date - Publication] Results: 1,092 |
| | Embase ((('cochlea prosthesis'/exp OR 'cochlear implantation'/exp OR 'cochlear implant' OR 'cochlear implantation') AND 'unilateral' OR 'cochlea prosthesis'/exp OR 'cochlear implantation'/exp OR 'sound processor') AND ('hearing impairment'/exp OR 'perception deafness'/exp OR 'unilateral hearing loss'/exp OR 'single-sided deafness' OR 'single sided deafness'/exp OR ('ssd' AND 'deaf') OR 'single-sided hearing loss' OR 'single sided hearing loss' OR 'unilaterally deaf' OR 'asymmetric hearing loss'/exp OR ('ahl' AND 'hearing') OR 'asymmetric deafness' OR 'asymmetrically deaf') AND ('nucleus'/dv OR nucleus OR ci2* OR ci4* OR ci5* OR ci6*) AND (cochlear/df OR cochlear) OR (('med el'/df OR 'med el' OR medel/df OR medel) AND 'cochlea') OR (('oticon medical'/df OR 'oticon medical') AND 'cochlea') OR ('advanced bionics'/df AND 'cochlea')) AND [01-01-2020]/sd NOT [31-12-2025]/sd Results: 1,209 |

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Table 4: Inclusion and Exclusion Criteria for Retrieved Literature

| Inclusion Criteria |
| --- |
| - Publications describing or focusing on the use of Cochlear Implant Systems - Publications describing non-clinical outcomes (e.g. tinnitus) - Meta-analysis and/or systematic review describing CI outcomes in SSD and AHL - Efficacy outcomes: single-study outcomes or randomized controlled trials as relevant in ≥10 patients - Safety outcomes: studies reporting adverse events or safety data, regardless of sample size or study design e.g., case reports - Reference published in peer-reviewed journal or book; - Reference referring to a study/studies performed on human subjects |
| Exclusion Criteria |
| - Duplicates - Repetitive/overlapping datasets - Single case reports (unless safety outcomes are reported) - Narrative reviews or systematic reviews with narrative synthesis - Publications where efficacy data is visually presented (e.g., graph only) and do not report on safety data - Publications where outcomes cannot be differentiated between subjects using AB devices and subjects using comparator devices - Non-human studies (e.g., in vitro, in vivo, animal, cadaver, phantom studies, simulations) - Non-peer reviewed (e.g., letters to editor, opinions, editorials etc.) - Conference abstracts, presentations or posters |

The following flow chart describes how the literature was initially identified, screened, reviewed, and the final determination of the relevant literature.

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Figure 2: Flowchart for how the literature review was constructed

Of the 35 identified references, 4 were systematic reviews. The references used within these reviews were screened for relevance, but the systematic reviews themselves are not included.

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### 1. Outcomes in Adults

The systematic literature review yielded 22 peer reviewed articles reporting on the effectiveness of CI in adult SSD and AHL patients and three peer reviewed articles reporting on the effectiveness of CI in a mix of adult and pediatric SSD and AHL patients. Across the 25 studies identified as relevant to the review question, data from a total of 1020 adults with SSD or AHL were reviewed. A summary of the literature is provided in Table 5 below.

Table 5: Adult Literature Review Results

| Study | Key Results |
| --- | --- |
| Achena, A., et al. (2022). | After cochlear implant surgery, concerning the preimplantation daily listening condition, a significantly improved speech perception score in silence and noise was found in all four groups (\( p < 0.05 \) for all). |
| Asfour, L., et. al (2025) | A total of 122 adults were evaluated. Mean age was \( 56.3 (\pm 13.0) \) years, and \( 59.8\% \) were male. Mean SSD duration was \( 10.8 (\pm 15.8) \) years. The most common etiology was sudden sensorineural hearing loss. The top primary motivations were improving overall hearing (\( 23.0\% \)), restoring hearing to the deaf ear (\( 22.1\% \)), and improving hearing in noise (\( 21.3\% \)). Most patients (\( 45.1\% \)) opted for a hearing aid, CROS or BiCROS system; \( 38.5\% \) chose CI; and \( 14.8\% \) declined treatment. Only \( 57.4\% \) of those who selected CI had the implant, primarily due to surgery avoidance (\( 31.5\% \)) and insurance limitations (\( 10.5\% \)). Motivation did not predict treatment choice or CI receipt. Among CI recipients (\( n = 27 \)), those motivated by hearing restoration demonstrated poorer speech outcomes and datalogging. |
| Astefanei, et. al. (2025). | In adult CI users, localization error significantly decreased from \( 81.9^{\circ} \pm 15.8^{\circ} \) to \( 43.7^{\circ} \pm 13.5^{\circ} \) (\( p < 0.001 \)). In children, regardless of the implant type (CI or BCI), localization error improved from \( 74.3^{\circ} \) to \( 44.8^{\circ} \), indicating a consistent spatial benefit. In adult BCI users, localization error decreased from \( 74.6^{\circ} \) to \( 69.2^{\circ} \), but the improvement did not reach statistical significance. Tinnitus severity, measured on a 10-point VAS scale, decreased significantly in CI users (mean reduction: \( 2.8 \pm 2.0 \), \( p < 0.001 \)), while changes in BCI users were small and of limited clinical relevance. SSQ12B/C scores improved in all adult groups, with the largest gains observed in spatial hearing for CI users (\( 2.1 \pm 1.2 \)) and in speech understanding for BCI users (\( 1.6 \pm 0.9 \)); children reported high benefits across all domains. Head shadow yielded the most consistent benefit across all groups (up to 4.9 dB in adult CI users, 3.8 dB in adult BCI users, and 4.6 dB in children). Although binaural effects were smaller in BCI users, positive gains were observed, especially in pediatric cases. Correlation analysis showed that daily device use positively predicted SSQ12 improvement (\( r = 0.57 \)) and tinnitus relief (\( r = 0.42 \)), while longer deafness duration was associated with poorer localization outcomes (\( r = -0.48 \)). |
| Dillon, M. T., et al (2020) | A prospective clinical trial evaluated the effectiveness of cochlear implantation in adults with AHL. Twenty subjects with mild-to-moderate hearing loss in the better ear and moderate-to-profound hearing loss in the poorer ear underwent cochlear implantation of the poorer hearing ear. Subjects were evaluated preoperatively and at 1, 3, 6, 9, and 12 months post-activation. Preoperative |

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| Study | Key Results |
| --- | --- |
| | performance was evaluated unaided, with traditional HAs or with a BAHA. Post-activation performance was evaluated with the cochlear implant (CI) alone or in combination with a contralateral HA (bimodal). Test measures included subjective benefit, word recognition, and spatial hearing (i.e., localization and masked sentence recognition). Significant subjective benefit was reported as early as the 1-month interval, indicating better performance with the CI compared with the preferred preoperative condition. Aided word recognition with the CI alone was significantly improved at the 1-month interval compared with preoperative performance with an HA and continued to improve through the 12-month interval. Subjects demonstrated early, significant improvements in the bimodal condition on the spatial hearing tasks compared with baseline preoperative performance tested unaided. The magnitude of the benefit was reduced for subjects with AHL when compared with published data on CI users with normal hearing in the contralateral ear; this finding may reflect significant differences in age at implantation and hearing sensitivity across cohorts |
| Diong, H. T., et al (2024). | To report a case of cochlear implantation with a misplaced electrode array in the vestibule and the causes for the delay in identification. A 23-year-old male with left single-sided deafness underwent cochlear implantation. The intraoperative assessment did not reveal any major red flags of electrode array misplacement. He did not display any vestibular symptoms postoperatively but showed poor speech performance, even though the aided tone audiometry revealed good sound detection thresholds. High-resolution computed tomography (HRCT) showed that the entire perimodolar electrode array was situated within the vestibule, and a revision surgery was conducted. Retrospective analysis of the neural response telemetry (NRT) revealed subtle differences in responses between the misplaced and correctly placed electrode arrays. Unlike previously reported cases, the patient did not display vestibular symptoms despite the misplacement of the electrode in the vestibule due to existing weakness in otolithic function. Further investigation is warranted when a motivated patient with normal inner ear anatomy does not show benefit with the cochlear implant post-operatively. One patient had a Misplacement of electrode array in the vestibule and a Reimplantation |
| Firszt, J. B., et al. (2023). | Forty adults with AHL from four, metropolitan CI centers participated. Hearing criteria for the ear to be implanted included: 1) pure tone average (PTA, .5, 1, 2 kHz) of >70 dB HL, 2) aided, monosyllabic word score of ≤30%, 3) duration of severe-to-profound hearing loss of ≥6 months, and 4) onset of hearing loss ≥6 years of age. Hearing criteria for the better ear (BE) included: 1) PTA (.5, 1, 2, 4 kHz) of 40–70 dB HL, 2) currently using a HA, 3) aided, word score of >40%, and 4) stable hearing for the previous 1-year period. Speech perception and localization measures, in quiet and in noise, were administered pre-implant and at 3m, 6m, 9m, and 12m post-implant. Pre-implant testing was performed in three listening conditions, PE HA, BE HA and bilateral HAs. Post-implant testing was performed in three conditions, CI, BE HA and bimodal. Outcome factors included age at implantation and length of deafness in the PE. A |

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| Study | Key Results |
| --- | --- |
| | hierarchical nonlinear analysis predicted significant improvement in the PE by 3m post-implant vs. pre-implant for audibility and speech perception with a plateau in performance at approximately 6m. The model predicted significant improvement in post-implant, bimodal outcomes vs. pre-implant outcomes (bilateral HAs) for all speech perception measures by 3m. Both age and length of deafness were predicted to moderate some CI and bimodal outcomes. In contrast to speech perception, localization in quiet and noise was not predicted to improve by 6m when comparing bilateral HAs (pre-implant) to bimodal (post-implant) outcomes. However, when participants' pre-implant everyday listening condition (BE HA or bilateral HAs) was compared to bimodal performance, the model predicted significant improvement by 3m for localization in quiet and noise. Lastly, BE HA results were stable over time; a generalized linear model analysis revealed bimodal performance was significantly better than performance with a BE HA at all post-implant intervals for most speech perception measures and localization. |
| Han, J. S., et al. (2025). | This retrospective study enrolled adult AHL/SSD patients with significant tinnitus who underwent CI or BCI placement between 2017 and 2023. Clinical characteristics, preoperative and postoperative audiologic test results, and tinnitus questionnaires (THI, VAS) were collected and analyzed. Of 33 AHL/SSD patients with significant tinnitus (THI ≥18), 16 received CI and 17 BCI. In the CI group, all four VAS scores (loudness, awareness, annoyance, and effect on life) and THI scores significantly improved. In the BCI group, annoyance and effect on life categories of VAS and THI scores significantly improved, while VAS loudness and awareness remained similar. Linear mixed model analysis showed that the decrease in VAS loudness, awareness, and annoyance scores was significantly greater in the CI group compared to the BCI group. The CI group showed a significantly higher tinnitus cure rate (62.5.0%) compared with the BCI group (11.8%) at 6-months postoperative. |
| Häußler, S. M., et al. | In total, 21 patients (8 male and 13 female) were included, and the Charité Test Battery was applied for all patients. Data on HRQoL were collected with the Nijmegen Cochlear Implant Questionnaire and the Medical Outcome Study Short Form 36 (SF-36) Survey. Tinnitus distress was assessed with the Tinnitus Questionnaire (TQ). Data with regard to psychological comorbidities were collected using four validated questionnaires. Speech perception was assessed with the Freiburg Monosyllable Test (FMS), the Oldenburg Sentence Test (OLSA), and the Oldenburg Inventory (OI). HRQoL improved in the subdomain social interactions. Tinnitus distress dropped significantly 6 months postoperatively. SSD patients preoperatively showed elevated levels of stress, depressive symptoms, and anxiety. Postoperatively, these psychological symptoms improved with regard to stress, tension, and demands. The audiometry tools revealed a significant improvement in directional hearing (OI), speech perception in silence, and in the speech intelligibility threshold (OLSA). |
| Holden, L. K., et al. | The study aimed to improve outcomes in Nucleus cochlear implant (CI) recipients with SSD by reducing interaural frequency and loudness mismatches |

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| Study | Key Results |
| --- | --- |
| (2025). | through device programming. In Experiment 1a, a modified frequency allocation table (FAT) was created to better match the tonotopicity of the contralateral ear and reduce interaural frequency mismatch. Twenty experienced SSD-CI users completed localization and speech recognition tests with their everyday FAT. Tests were repeated after 6 weeks' use of the modified FAT. Participants compared both FATs for 2 weeks before being tested again with each. For 10 newly implanted SSD-CI recipients (Experiment 1b), Group A was programmed with the manufacturer's default FAT and Group B with the modified FAT at activation. Speech recognition and localization were completed, after 6 weeks' use of each FAT. Participants then compared both FATs before testing with each. In Experiment 2, 15 experienced SSD-CI users were evaluated with their everyday program and a modified loudness program, which was created to obtain audibility of ~20 dB HL from 0.25 to 6 kHz and balanced loudness between ears. Three test sessions occurred, resembling Experiment 1a. Experienced participants in Experiments 1a and 2 showed significant improvement in one speech-in-noise task with a modified program compared to the everyday program. Newly implanted recipients showed no significant difference in results between FATs. Results indicate that modified programs, created to reduce interaural mismatches, may improve outcomes. The first month after activation might be too early to compare FATs as SSD-CI recipients are adjusting to electric hearing |
| Kurz, A., et al (2025). | Twelve SSD CI users with postlingual hearing loss. OTOPLAN (Version 3. (MED-EL) was used to determine intracochlear electrode contact positions using post-operative high-resolution flat panel volume computed tomography. From these positions, the corresponding center frequencies and bandwidths were derived for each channel. These were implemented in the clinical fitting software MAESTRO to yield an ABF map individualized to each user. Significantly higher speech perception in noise scores were observed with the ABF map compared to the CBF map (mean SRT50: -6.49 vs. -4.8 dB SNR for the \( S_0N_{CI} \) configuration and -3.85 vs. -2.75 dB SNR for the \( S_0N_0 \) configuration). Summation and squelch effects were significantly increased with the ABF map (0.86 vs. 0.21 dB SNR for summation and 0.85 vs. -0.09 dB SNR for squelch). No improvement in speech perception in quiet or spatial release from masking were observed with the ABF map. A similar level of self-perceived sound quality was reported for each map. Upon the end of the study, all users opted to keep the ABF map. This preference was independent of the angular insertion depth of the electrode array. |
| Lentz, B, et al (2025) | Twelve SSD CI patients underwent a 4-week training program. Twice a week, subjects completed training sessions of approximately 30 minutes, each involving 50 stimuli presented by 7 loudspeakers arranged from -90 to +90 degrees in the horizontal plane. Spatial hearing was evaluated before and after training using the root mean square error (RMSE), the mean absolute error (MAE), and the bias of source location angles, and by the Speech, Spatial and Quality of Hearing Scale (SSQ) questionnaire. Localization abilities assessed |

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| Study | Key Results |
| --- | --- |
| | by MAE and by RMSE were better with CI than without (p < 0.001), but further significantly improved after spatial auditory training (both p < 0.05), especially for signals presented from the frontal direction. Furthermore, subjective spatial hearing abilities measured by the SSQ also improved after training (p < 0.01). Subjects with a larger pretraining bias showed a greater reduction in bias after training. |
| Lindquist, N. R., et al (2023) | This is a retrospective case series for adults with SSD who underwent CI between January 2013 and May 2021 at our institution. CNC and AzBio speech recognition scores, THI, SSQ12, datalogging, and the Cochlear Implant Quality of Life (CIQOL)-10 Global measure were utilized. Sixty-six adults underwent CI for SSD (median 51.3 years, range 20.0 to 74.3 years), and 57 (86.4%) remained device users at last follow-up. Compared to pre-operative performance, device users demonstrated significant improvement in speech recognition scores and achieved peak performance at six months post-activation for CNC (8.0% increased to 45.6%, p<0.0001) and AzBio in quiet (12.2% increased to 59.5%, p<0.0001). THI was decreased at 6 months post-implantation (58.1 to 14.6, p<0.0001), with 77% of patients reporting improved or resolved tinnitus. Patients demonstrated improved SSQ12 scores as well as the disease-specific CIQOL-10 Global questionnaire. Duration of deafness (DoD) was not associated with significant differences in speech recognition performance. Average daily wear time was positively associated with CNC and AzBio scores as well as post-operative CIQOL-10 scores. |
| Marx, M, et al (202…