Intrisound Tuned Lumen® 155 Hearing Aids
Device Facts
| Record ID | K223848 |
|---|---|
| Device Name | Intrisound Tuned Lumen® 155 Hearing Aids |
| Applicant | Tuned , Ltd. |
| Product Code | QUH · Ear, Nose, Throat |
| Decision Date | Sep 8, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3325 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance of a hearing healthcare professional.
Device Story
Wireless, self-fitting air-conduction hearing aid; BTE (Receiver-in-Aid) form factor. Inputs: ambient sound via bi-directional microphones. Processing: digital signal processing (16-channel wide dynamic input compression, 3-layer fast-acting output compression, 16-channel noise reduction, feedback cancellation, 12-band equalizer). User interface: Tuned Mobile Application (iOS/Android) for self-testing auditory thresholds and device programming. Output: amplified sound. Used in home/daily environments by patients. Healthcare providers do not assist in fitting. Benefits: improved hearing for mild-to-moderate impairment; user-customized sound profiles based on self-administered hearing tests.
Clinical Evidence
Two prospective, crossover studies (N=30 and N=41). Study 1 validated Tuned self-test thresholds against professional audiometry (Total MAD 5.25 dB, 95% CI 4.73-5.78 dB) and self-fitting against professional fitting (Total MAD 3.37 dB, 95% CI 3.2-3.53 dB). Study 2 compared subjective outcomes (COSI, IOI-HA) between self-fitting and professional fitting; results showed non-inferiority of self-fitting. No adverse events reported.
Technological Characteristics
BTE (Receiver-in-Aid) hearing aid. Materials: biocompatible. Sensing: bi-directional microphones. Energy: 1.45V size 312 zinc-air battery. Connectivity: Bluetooth. Processing: 16-channel digital signal processing, 12-band equalizer, adaptive feedback cancellation. Standards: ANSI ASA S3.22, ANSI ASA S3.6, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-66, IEC 62304.
Indications for Use
Indicated for individuals 18 years of age or older with perceived mild to moderate hearing impairment. Intended for self-fitting without professional assistance.
Regulatory Classification
Identification
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.
Special Controls
In combination with the general controls of the FD&C Act, the self-fitting air-conduction hearing aid is subject to the following special controls: - 1. Clinical data must evaluate the effectiveness of the self-fitting strategy. - 2. Electroacoustic parameters, including maximum output limits, distortion levels, selfgenerated noise levels, latency, and frequency response, must be specified and tested. - 3. Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. - 4. Software verification, validation, and hazard analysis must be performed. - 5. If the device incorporates wireless technology: - (A) Performance testing must validate safety of exposure to non-ionizing radiation; - (B)Performance data must validate wireless technology functions; and - (C) Labeling must specify instructions, warnings, and information relating to wireless technology and human exposure to non-ionizing radiation. - 6. Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use. - 7. Patient labeling must include the following: - (A)Information on how a patient can self-identify as a candidate for the device; - (B) Information about when to seek professional help; - (C) A warning about using hearing protection in loud environments; - (D) A warning about staying alert to sounds around the user of the device; - (E) Technical information about the device, including information about electromagnetic compatibility; and - (F) Information on how to correctly use and maintain the device.
*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy. (2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested. (3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) If the device incorporates wireless technology: (i) Performance testing must validate safety of exposure to non-ionizing radiation; and (ii) Performance data must validate wireless technology functions. (6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
Predicate Devices
- BHA100 Series Braun® Clear™ Hearing Aid (K212609)
Related Devices
- K223137 — Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application · Hearx SA (Pty) , Ltd. · Mar 14, 2023
- K211008 — Bose SoundControl Hearing Aids · Bose Corporation · May 5, 2021
- K220303 — MDHearingAid app, MDHearingAid Smart hearing aids · Mdhearingaid · Aug 4, 2022
- K212609 — BHA100 Series Braun Clear Hearing Aid · Kaz USA, Inc., A Helen of Troy Company · Jan 5, 2022
- DEN180026 — Bose Hearing Aid · Bose Corporation · Oct 5, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2023
Tuned Ltd % Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant (ProMedoss, Inc.) ProMedoss Inc 3521 Hatwynn Road Charlotte, North Carolina 28269
Re: K223848
Trade/Device Name: Intrisound™ Tuned Lumen® 155 Hearing Aids Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: August 10, 2023 Received: August 11, 2023
Dear Shoshana (Shosh) Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K223848
Device Name Intrisound™M Tuned Lumen® 155 Hearing Aids
#### Indications for Use (Describe)
Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized "C" shape made up of concentric arcs in shades of blue and purple, followed by the word "TUNED" in a simple, sans-serif font. A small "TM" symbol is placed to the upper right of the word "TUNED".
# 510(K) SUMMARY Intrisound™ Tuned Lumen® 155 Hearing Aids 510(k) Number K223848
#### 1. SUBMITTER
Applicant's Name and Address: Tuned Ltd. 18 Harimon St, Gan Yoshiya Israel, 3885000
Primary Contact: Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: (704) 430-8695 Email: s.friedman@promedoss.com
510(k) Summary Prepared on: September 5, 2023
#### 2. SUBJECT DEVICE
Trade Name: Intrisound™ Tuned Lumen® 155 Hearing Aids
Classification: Name: Self-Fitting Air-Conduction Hearing Aid, Over The Counter Product Code: OUH Regulation No: 21 CFR 874.3325 Class: 2 Review Panel: Ear Nose & Throat
#### 3. PREDICATE DEVICE
BHA100 Series Braun® Clear™ Hearing Aid cleared under K212609
#### REFERENCE DEVICE বঁ
None
#### DEVICE DESCRIPTION 5.
The Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid. It features digital signal processing (16 channel wide dynamic input compression, 3 layer fastacting output compression, 16 channel noise reduction, feedback cancellation), bi-directional microphone with windscreen, volume and program control, 12 band equalizer, self-selectable tube and ear tips, and customization through the Tuned Mobile Application. The Tuned Mobile Application aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Intrisound™ Tuned Lumen® 155 Hearing Aid. These thresholds are used to program the device using a proprietary algorithm.
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Image /page/4/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left, followed by the word "TUNED" in a sans-serif font. A small trademark symbol is located to the upper right of the word "TUNED".
#### INTENDED USE/INDICATIONS FOR USE 6.
The Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
## 7. LABELING
Self-selection labeling has been included in the Intrisound™ Tuned Lumen® 155 Hearing Aid User Manual (UM) to mitigate the risk of improper self-selection. The information includes the following:
- Identifying situations in which the Intrisound™ Tuned Lumen® 155 Hearing Aid may help . users hear better.
- . Identifying situations in which the Intrisound™ Tuned Lumen® 155 Hearing Aid may not be right for users.
- Identifying criteria that indicate users should see a hearing professional. .
- . Informing users that the Intrisound™ Tuned Lumen® 155 Hearing Aid will not restore normal hearing.
- Informing users that it is good health practice to have hearing loss evaluated by a licensed . healthcare professional.
Additionally, the Intrisound™ Tuned Lumen® 155 Hearing Aid User Manual (UM) contains information about the Remote Support Service and the Call Center Telephone Support Service that is available to the users to address concerns and optimize product functionality.
#### 8. SPECIAL CONTROLS
The Intrisound™ Tuned Lumen® 155 Hearing Aid conforms to the special controls stated in 21 CFR 874.3325. These requirements were satisfied through the following:
- Clinical Performance Validation ●
- Non-Clinical Performance Testing .
- Summative Usability / Human Factors Validation ●
- . Labeling
#### 9. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Intrisound™ Tuned Lumen® 155 Hearing Aid has the same intended use and fundamental technology as the predicate device , the BHA100 Series Braun® Clear™ Hearing Aid. In the same manner as its predicate device, the Intrisound™ Tuned Lumen® 155 Hearing Aid a user-fitted wireless air-conduction hearing aid intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment.
The same fundamental scientific technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs. The subject device is essentially equivalent to the predicate device in product design, dimension, use of Bluetooth technology and utilizing biocompatible materials of high standard.
Table 1 below provides a summarized comparison between the subject device and the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of three concentric arcs in shades of blue and purple. The TM symbol is located in the upper right corner of the word "TUNED".
# Table 1: Comparison Table
| Characteristic | PREDICATE DEVICE<br>BHA100 Series Braun®<br>Clear™ Hearing Aid | SUBJECT DEVICE<br>Intrisound™ Tuned<br>Lumen® 155<br>Hearing Aid | Comparison Analysis |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212609 | K223848 | NA |
| Product Code | QDD | QUH | The OTC version of the self-<br>fitting hearing aid has a<br>different product code (QUH)<br>than when the predicate device<br>was originally cleared as a<br>self-fitting hearing aid. The<br>only differences relevant to<br>this change are updated<br>labeling, design, and<br>performance characteristics<br>required by 800.30 for OTC<br>hearing aids by the enactment<br>of the OTC Hearing Aid Final<br>Rule that became effective on<br>October 17, 2022 |
| Regulation | 21 CFR 874.3325 | 21 CFR 874.3325 | Same |
| Classification<br>Name | Self-Fitting Air-Conduction<br>Hearing Aid, Prescription | Self-Fitting Air-Conduction<br>Hearing Aid, Over The<br>Counter | - |
| Intended Use | The BHA100 Series Braun®<br>Clear™ Hearing Aid is a<br>self-fitting, air conduction<br>hearing aid, intended to<br>amplify sound for individuals<br>18 years of age or older with<br>perceived mild to moderate<br>hearing impairment. It is<br>adjusted by the user to meet<br>the user's hearing needs. The<br>device is intended for direct-<br>to-consumer sale and use<br>without the assistance of a<br>hearing health care<br>professional. | The Intrisound™ Tuned<br>Lumen® 155 are self-fitting,<br>wireless air conduction<br>hearing aids, intended to<br>amplify sound for individuals<br>18 years of age or older with<br>perceived mild to moderate<br>hearing impairment. They are<br>adjusted by the user to meet<br>the user's hearing needs. The<br>device is intended for use<br>without the assistance of a<br>hearing healthcare<br>professional. | The intended use of the subject<br>device is similar to the<br>intended use of the predicate<br>device with the appropriate<br>adjustment in accordance with<br>the OTC Hearing Aid Final<br>Rule. |
| Device<br>Description | The BHA100 Series Braun®<br>Clear™ Hearing Aid is a<br>self-fitting, air conduction<br>hearing aid. It features digital<br>signal processing (16<br>channel-wide dynamic input<br>compression, 3 channel fast-<br>acting output compression,<br>16 channel noise reduction,<br>feedback cancellation) | The Intrisound™ Tuned<br>Lumen™ 155 Hearing Aid is<br>a wireless, self-fitting air<br>conduction hearing aid. It<br>features digital signal<br>processing (16 channel wide<br>dynamic input compression,<br>3 layer fast-acting output<br>compression, 16 channel<br>noise reduction, feedback | The two devices are similar,<br>with additional equalizer<br>adjustments in the subject<br>device, which do not introduce<br>any new safety or effectiveness<br>concerns. Performance testing<br>supports the substantial<br>equivalence. |
| Characteristic | PREDICATE DEVICE<br>BHA100 Series Braun®<br>Clear™ Hearing Aid | SUBJECT DEVICE<br>Intrisound™ Tuned<br>Lumen® 155<br>Hearing Aid | Comparison Analysis |
| | directional microphone with<br>windscreen, volume and<br>program control<br>(environment selection –<br>Quiet, Noisy, Concert, TV), 3<br>channel equalizer, self-<br>adjustable wire and ear tips,<br>and customization through<br>the Braun® Clear™ Mobile<br>Application. The Braun®<br>ClearCheck™ Hearing Test<br>aims to detect accurate<br>auditory thresholds,<br>partnering with a smart<br>phone application to deliver<br>user-customized sound<br>through the Braun® Clear™<br>Hearing Aid. These<br>thresholds are used to<br>program the device using a<br>proprietary fitting algorithm. | cancellation), bi-directional<br>microphone with windscreen,<br>volume and program control,<br>12 band equalizer, self-<br>selectable tube and ear-tip<br>(dome), and customization<br>through the Tuned Mobile<br>Application. The Tuned<br>Mobile Application aims to<br>detect accurate auditory<br>thresholds, partnering with a<br>smart phone application to<br>deliver user-customized<br>sound through the<br>Intrisound™ Tuned Lumen®<br>155 Hearing Aid. These<br>thresholds are used to<br>program the device using a<br>proprietary algorithm. | |
| Technology | Wireless, self-fitting air<br>conduction hearing aid | Wireless, self-fitting air<br>conduction hearing aid | Same |
| Housing | BTE (Receiver-in-Canal) | BTE (Receiver-in-Aid) | Similar<br>Both devices are BTE with a<br>difference being that the<br>subject device uses the<br>Receiver-in-Aid assembly<br>instead of a Receiver-in-Canal<br>assembly.<br>Performance testing supports<br>the substantial equivalence. |
| Power On-Off | Through battery door:<br>Closed = power ON<br>Open = power OFF | Through battery door:<br>Closed = power ON<br>Open = power OFF | Same |
| Ear-Tips | Two models: Open dome<br>(sizes S, M, L), Closed dome<br>(sizes S, M, L) | Three models: Tulip dome<br>(one size); Double dome<br>(sizes S, M, L), Open dome<br>(sizes S, M, L) | Similar.<br>The subject device offers an<br>additional ear-tip model.<br>Performance testing supports<br>the substantial equivalence |
| Mobile App | Mobile application on a<br>smartphone with either iOS<br>or Android platforms. | Mobile application on a<br>smartphone with either iOS<br>or Android platforms. | Same |
| Wireless<br>Communication | Bluetooth protocol | Bluetooth protocol | Same |
| Wireless User<br>Control Functions | Volume control, program<br>change selection, settings | Volume control, program<br>change selection, settings | Same |
| Characteristic | PREDICATE DEVICE<br>BHA100 Series Braun®<br>Clear™ Hearing Aid | SUBJECT DEVICE<br>Intrisound™ Tuned<br>Lumen® 155<br>Hearing Aid | Comparison Analysis |
| Bluetooth Pairing<br>and Control | Pairing and control<br>verification with the paired<br>mobile device. | Pairing and control<br>verification with paired<br>mobile device. | Same |
| Power Source | Replaceable, disposable, 1.45<br>Volt, size 312, zinc air<br>battery | Replaceable, disposable, 1.45<br>Volt, size 312, zinc air<br>battery | Same |
| Microphones | Bi-directional microphones<br>with windscreen | Bi-directional microphones<br>with windscreen | Same |
| Device Control | On device and through<br>mobile app | On device and through<br>mobile app | Same |
| Compression | 16 channel, input controlled,<br>output limiting | 16 channel, input controlled,<br>output limiting | Same |
| Noise Reduction | 16 channel | 16 channel | Same |
| Feedback<br>Cancellation | Adaptive | Adaptive | Same |
| Telephone Calls | None | None | Same |
| Self-Fitting<br>Method | NAL-NL2 based | NAL-NL2 based propriety<br>algorithm | Similar.<br>Performance testing supports<br>the substantial equivalence. |
| Remote Firmware<br>Update | None | None | Same |
| Latency | Complies with ANSI CTA<br>2051-2017 which requires<br>latency ≤ 15 ms | Complies with (e)(3) of 21<br>CFR 800.30 and with ANSI<br>CTA 2051-2017 which<br>requires latency ≤ 15 ms | Similar.<br>Performance testing supports<br>the substantial equivalence. |
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Image /page/6/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The letters in "TUNED" are a dark blue color, and there is a small "TM" symbol in the upper right corner of the word.
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Image /page/7/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple, while the word "TUNED" is in a dark blue color, with a trademark symbol in the upper right corner.
# ANSI ASA S3.22 Specification of Hearing Aid Characteristics
In order to demonstrate substantial equivalence with the predicate device, the Intrisound™ Tuned Lumen® 155 Hearing Aid was evaluated per ANSI ASA S3.22 for acoustic performance. These results are summarized in Table 2 below.
| Characteristic | PREDICATE DEVICE<br>BHA100 Series Braun®<br>Clear™ Hearing Aid | SUBJECT DEVICE<br>Intrisound™ Tuned<br>Lumen® 155<br>Hearing Aid | Comparison Analysis |
|----------------|----------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| OSPL90 Curve | Image: Graph of OSPL90 Curve for PREDICATE DEVICE | Image: Graph of Frequency Response - Left and dB Gain for SUBJECT DEVICE | Comparable.<br>Performance testing supports<br>the substantial equivalence. |
## Table 2: ANSI ASA S3.22 Performance Data
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Image /page/8/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The TM symbol is located to the upper right of the word TUNED.
| Characteristic | PREDICATE DEVICE<br>BHA100 Series Braun®<br>Clear™ Hearing Aid | SUBJECT DEVICE<br>Intrisound™ Tuned<br>Lumen® 155<br>Hearing Aid | Comparison Analysis |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Max OSPL90 | 120 dB SPL | 114.4 dB SPL | The maximum output of the<br>subject device is lower than the<br>predicate device to comply<br>with the requirements of<br>21CFR800.30 for OTC hearing<br>aids.<br>Performance testing supports<br>the substantial equivalence. |
| High Frequency<br>Average OSPL90<br>(HFA OSPL90) | 111 ± 2 dB SPL | 109.6 ± 2 dB SPL | Both devices meet the<br>requirements of the standard. |
| High Frequency<br>Average Full-on<br>Gain (HFA FOG) | 40 ± 2 dB | 40 ± 2 dB | Both devices meet the<br>requirements of the standard. |
| Reference Test<br>Gain (RTG) | 34 ± 4 dB | 34 ± 4 dB | Both devices meet the<br>requirements of the standard. |
| Frequency<br>Response | 200 Hz to 8000 Hz | 200 Hz to 8000 Hz | Both devices meet the<br>requirements of the standard. |
| Frequency Range | <200-8000 Hz | <200 Hz to 7100 Hz | Difference in range is due to<br>the acoustic bandwidth<br>limitations of the Receiver-in-<br>Aid. This difference does not<br>introduce new safety or<br>effectiveness concerns and<br>performance testing supports<br>the substantial equivalence. |
| Harmonic<br>Distortion | From Engineering Product<br>Specifications:<br>500 Hz ≤ 1.5%<br>800 Hz ≤2.0%<br>1600 Hz ≤ 3.0% | 500 Hz ≤ 5.0%<br>800 Hz ≤ 5.0%<br>1600 Hz ≤ 5.0% | The subject device complies<br>with ANSI CTA 2051-2017<br>and 21CFR800.30 that requires<br>total harmonic distortion to be<br>less than 5%. |
| Equivalent Input<br>Noise (EIN) | <29 dB SPL | <27 dB SPL | Both devices meet the<br>requirements of the standard. |
| Battery Current | 2.5 mA | 1.2 mA | Both devices meet the<br>requirements of the standard. |
# ANSI ASA S3.6 Specifications for Audiometers
Like the Braun® ClearCheck™ Hearing Test feature of the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid, also the Tuned App of the Intrisound™ Tuned Lumen® 155 Hearing Aid was designed to conform to the applicable clauses of ANSI ASA S3.6, as listed in Table 3.
| Table 3: ANSI ASA S3.6 Applicable Clauses | | | | |
|-------------------------------------------|--|--|--|--|
|-------------------------------------------|--|--|--|--|
| Clause # | Clause Title |
|----------|----------------------------------|
| 5.4.3 | Unwanted sounds from an earphone |
| 6.1.1 | Frequencies and hearing levels |
| 6.1.4 | Frequency accuracy |
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Image /page/9/Picture/0 description: The image shows the word "TUNED" in a sans-serif font. To the left of the word is a graphic of three curved lines that resemble sound waves. The color of the graphic transitions from light blue to dark blue to purple. The letters of the word "TUNED" are black, and there is a trademark symbol in the upper right corner of the letter D.
| Clause # | Clause Title |
|----------|------------------------------------------|
| 6.1.5 | Harmonic distortion |
| 7.2 | Accuracy of sound pressure for pure tone |
| 7.3.1 | Hearing level control increments |
| 7.3.3 | Hearing level control linearity |
| 7.5.2 | On/off ratio |
## 10. CLINICAL PERFORMANCE TESTING
The clinical performance of the Intrisound™ Tuned Lumen® 155 Hearing Aid was evaluated in several studies. Presented below are the two recent studies.
## STUDY 1: TU1-RPT-433, Tuned self-test and Tuned self-fitting outputs in comparison with professional hearing test and fitting outputs of hearing-impaired participants
## Studv Design
This study of the Intrisound™ Tuned Lumen® 155 Hearing Aid was a prospective, crossover, comparative study designed to validate results of the Tuned self-test compared to a traditional audiometry performed by a professional. In particular, this study aimed to validate a mean absolute difference (MAD) of less than 10 dB for each tested frequency (500, 1000, 2000 and 4000 Hz) between the Tuned self-test and the traditional audiometry and a total MAD1 of less than 10 dB. This study also aimed to demonstrate that:
- Tuned self-fitting is non inferior to the professional fitting by showing that the MAD from । NAL-NL2 per frequency of the Tuned self-fitting is within the range of 5 dB of the MAD from NAL-NL2 of the professional fitting.
- The total MAD of the Tuned self-fitting is within the range of 5 dB from the NAL-NL2 targets. -
- The total MAD of the real ear aided responses (REAR) of the Tuned self-fitting and the professional fitting is in the range of 5 dB.
- The maximum power output (MPO) measurements do not exceed 117 dB SPL in any volume control level.
The acceptance criteria presented above were set in accordance to the acceptance criteria applied in the clinical study of the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid, to support the substantial equivalence determination.
The crossover was applied by assigning half of the participants (odd participant numbers) to start with the standard clinical audiometry by a professional, then performed a hearing self-test while the other half (even participant numbers) started with performing the hearing test by themselves, then tested by a professional using standard clinical audiometry.
## Study Populations
The study was conducted among a population of 30 adults recruited from private hearing clinics. Table 4 below provides information on the study population.
| Characteristic | N / Total (%) |
|-----------------------|----------------|
| Age | |
| 18 to 40 years of age | 3 / 30 (10.0%) |
| 41 to 60 years of age | 4 / 30 (13.3%) |
### Table 4: Study 1 Population Summary
<sup>1 &</sup>quot;Total MAD" is the average MAD of all averaged over all tested frequencies.
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Image /page/10/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized graphic of concentric circles in shades of blue and purple, followed by the word "TUNED" in a simple, sans-serif font. A trademark symbol appears to the upper right of the word.
| Characteristic | N / Total (%) |
|---------------------------------------|------------------|
| 61 to 70 years of age | 7/30 (23.3%) |
| 71 to 80 years of age | 15 / 30 (50.0%) |
| 81 years of age and up | 1 / 30 (3.3%) |
| Sex | |
| Female | 15 / 30 (50.0%) |
| Male | 15 / 30 (50.0%) |
| Symmetric/Asymmetric Hearing Loss | |
| Symmetric | 21 / 30 (70.0%) |
| Asymmetric | 9 / 30 (30.0%) |
| Previous Experience with Hearing Aids | |
| Experienced User | 18 / 30 (60.0%) |
| New User | 12 / 30 (40.00%) |
## Study Results
The results of the primary endpoint, namely, the measured audiometric threshold for each tested frequency of Tuned self-test versus those measured by a licensed audiologist well correlated as shown in Figure 1(a). The mean and ±1 standard deviation of the hearing thresholds, per frequency, obtained by the Tuned self-test and by traditional clinical audiometry performed by a professional are shown in Figure 1(b). The total MAD of the Tuned self-test and the traditional audiometry performed by a professional averaged for all tested frequencies, shown in Figure 1(b), was 5.25 dB with a 95% confidence interval of 4.73 to 5.78 dB, which is well within the accepted criterion of less than 10 dB.
Image /page/10/Figure/4 description: The image is a boxplot comparing hearing thresholds in dB HL for a tuned self-test versus traditional audiometry by a professional. The x-axis represents frequency in Hz, with values of 500, 1000, 2000, and 4000. The y-axis represents hearing thresholds in dB HL, ranging from 0 to 90. The boxplots show the distribution of hearing thresholds for each frequency, with the tuned self-test generally showing lower thresholds than traditional audiometry.
Figure 1(a): Measured Audiometric Thresholds per Frequency
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Image /page/11/Picture/0 description: The image contains the word "TUNED" in a sans-serif font. To the left of the word is a graphic of concentric circles in shades of blue and purple. The letters of the word "TUNED" are in a dark blue color. The letters are all capitalized, and there is a trademark symbol to the right of the word.
Figure 1(b): Mean and ± 1 standard deviation of the hearing thresholds obtained by the Tuned selftest (Blue) and traditional clinical audiometry performed by a professional (Orange), per frequency
Image /page/11/Figure/2 description: The image shows a graph comparing hearing thresholds at different frequencies using two methods: a tuned self-test and traditional audiometry by a professional. The x-axis represents frequency in Hertz (Hz), with values at 500, 1000, 2000, and 4000 Hz. The y-axis represents hearing thresholds in decibels Hearing Level (dB HL), ranging from 0 to 80. The graph indicates that hearing thresholds generally increase with frequency for both methods, with traditional audiometry showing slightly higher thresholds than the tuned self-test.
The results of the secondary endpoints showed that:
- The MAD from NAL-NL2 per frequency of the Tuned self-fitting is well within the range of -5 dB of the MAD from NAL-NL2 of the professional fitting.
- The Tuned self-fitting MAD from NAL-NL2 for each frequency is less than 5 dB and the total -MAD from NAL-NL2 is 3.37 dB with a 95% Confidence Interval of 3.2 to 3.53 dB, well withing the acceptance criterion of 5 dB.
- The total MAD between the REAR of professional-fitting and Tuned self-fitting is 3.72 dB with a 95% Confidence Interval of 3.55 to -3.89 dB, well within the 5 dB acceptance criterion (see Figure 1(c)).
- All MPO measurements in the real ear were less than 117 dB SPL, well within the acceptance criterion of <117 dB SPL in all volume control levels.
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Image /page/12/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left, followed by the word "TUNED" in a clean, sans-serif font. A trademark symbol is located to the upper right of the word "TUNED".
Image /page/12/Figure/1 description: The image contains the title of a figure, specifically "Figure 1(c)". The figure displays the mean plus or minus one standard deviation of the REAR, which follows the Tuned self-fitting (Blue) and the professional Autofit (Orange). The data is presented per frequency. The title indicates that the figure likely compares the performance or characteristics of two different fitting methods, with the colors blue and orange used to distinguish between them.
Image /page/12/Figure/2 description: The figure is a plot of REAR (dB SPL) vs Frequency (Hz). The x-axis shows the frequency in Hz, ranging from 250 to 6000. The y-axis shows the REAR in dB SPL, ranging from 0 to 100. There are two lines plotted on the graph, one for 'Tuned self-fitting' and one for 'Professional Autofit', with error bars at each point.
In conclusion, this study supports the clinical performance of the Tuned solution, namely, the Tuned application with the Intrisound Lumen 155 hearing aids, and demonstrates that the Tuned solution is substantially equivalent to the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid, without raising any new safety or effectiveness concerns.
## STUDY 2: A prospective, crossover randomized controlled trial to compare subjective outcome of a self-fitting process using Tuned App to a licensed professional fitting (NCT05869266)
### Study Design
This study was a prospective, two-arm, two-site, crossover randomized controlled and comparative study, comparing outcomes of two fitting approaches, self-fitting with Tuned mobile app and licensed professional fitting with the same hearing aid device.
Note: Due to the inherent clinician involvement in the tuning process, this study was not investigator-blinded, nevertheless, the meticulous structure of the study aimed to ensure that the lack of blinding did not impact the effectiveness outcomes of the study.
### Study Objectives
The primary objective of the study was to compare the subjective outcomes of a self-fitting of the hearing aids done by the participant using the Tuned application and subjective fitting outcomes performed by a licensed professional using the standardized and validated Client Oriented Scale of Improvement (COSI) questionnaire tool.
The secondary objectives were to:
- Compare the subjective outcomes of a self-fitting of the hearing aids done by the 1. participant using the Tuned application and subjective fitting outcomes performed by a
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Image /page/13/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The "TM" symbol is located in the upper right corner of the word "TUNED".
licensed professional using the standardized and validated International Outcome Inventory- Hearing Aids (IOI-HA) questionnaire tool.
- Estimate the rate of device and self-fitting related adverse events. 2.
### Study Design & Procedures
In this prospective, two-arm, crossover randomized controlled and comparative study, two fitting approaches using the same hearing aid device were compared - self-fitting with Tuned mobile app and fitting by a licensed professional.
The overall flow of the study is presented in Figure 2 below.
Image /page/13/Figure/6 description: This image is a flowchart that shows the process of a study. The study has two groups, Group 1 and Group 2, and each group goes through a series of steps. The first step is a screening and baseline visit, followed by either self-fitting or pro-fitting depending on the group. After that, there is a phone visit, 2 weeks at home, and a crossover visit. Finally, the study ends with either pro-fitting or self-fitting depending on the group.
### Figure 2: Overall Study Flow
Participants in this study underwent the following procedures:
### Visit 1: Screening and Eligibility
Upon completion of the informed consent process, subjects underwent a screening process, which included a clinical hearing test conducted by a licensed professional. Subsequently, participants
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Image /page/14/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized icon resembling sound waves emanating from a central point, followed by the word "TUNED" in a clean, sans-serif font. A trademark symbol is placed to the upper right of the word "TUNED".
received hearing aids (HA) along with user manuals. Random assignment placed them into one of two groups:
Group 1: Participants received HA fitting performed by a licensed professional using professional programming tools and the thresholds obtained f…
