Who is the manufacturer of Lumen 155-SF?

Intricon Corporation filed the 510(k) submission for Lumen 155-SF (K223911).

What is the FDA product code for Lumen 155-SF?

QDD. It is classified under 21 CFR 874.3325 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Lumen 155-SF?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Lumen 155-SF?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Lumen 155-SF

Q: What are the predicate devices for Lumen 155-SF?

Nuheara IQbuds™ 2 PRO (K221064).

K223911 · Intricon Corporation · QDD · Oct 17, 2023 · Ear, Nose, Throat

Device Facts

Record ID	K223911
Device Name	Lumen 155-SF
Applicant	Intricon Corporation
Product Code	QDD · Ear, Nose, Throat
Decision Date	Oct 17, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3325
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Lumen® 155-SF self-fitting, wireless air conduction hearing aids are 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 over-the-counter sales without the assistance of a hearing health care professional.

Device Story

Lumen 155-SF is a behind-the-ear (BTE) self-fitting wireless air-conduction hearing aid. Input: ambient sound via bi-directional microphones. Transformation: digital signal processing (DSP) including wide dynamic range compression, noise reduction, feedback cancellation, and wind noise suppression. Output: amplified sound delivered to ear canal via slim tube and ear tip. Operation: user-controlled via Sentibo iOS app; requires wired Apple EarPods with lightning connector for initial self-assessment. User selects hearing profile from 24 options based on digitized speech stimuli; settings transferred to hearing aid. Used by patients in home/daily environments. Benefits: improved hearing for mild-to-moderate impairment without professional intervention. Healthcare provider role: none; device is OTC. Clinical decision-making: user-driven adjustment based on perceived benefit.

Clinical Evidence

Multicenter, prospective, randomized, single-blind, parallel-arm study (n=92) compared self-fitting (Sentibo app) vs. professional-fitting. Primary endpoint: non-inferiority of satisfaction (sound quality/fitting process). Secondary: APHAB and SSQ-12 scores. Results: Self-fit group satisfaction and perceived benefit were non-inferior to professional-fit. Exploratory: simulated real-ear measures confirmed output matches NAL-NL2 targets. No significant adverse events reported.

Technological Characteristics

BTE form factor; 1.45V size 312 zinc-air battery. Biocompatible materials (ISO 10993-1). Features: 16-band DSP, adaptive/fixed microphone directionality, feedback cancellation, noise reduction. Connectivity: Bluetooth (for app control). Software: Sentibo iOS app for self-fitting. Sterilization: N/A (non-sterile). Standards: ANSI/ASA S3.22, ANSI/CTA 2051, IEC 60118-13, BS EN 60601-2-66.

Indications for Use

Indicated for adults 18+ with perceived mild to moderate hearing impairment. No contraindications specified beyond standard hearing aid exclusions (e.g., significant middle ear disease, congenital anomaly).

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

Nuheara IQbuds™ 2 PRO (K221064)

Reference Devices

Bose Sound Control (K211008)
Bose De Novo (DEN180026)

Related Devices

K223848 — Intrisound Tuned Lumen® 155 Hearing Aids · Tuned , Ltd. · Sep 8, 2023
K220303 — MDHearingAid app, MDHearingAid Smart hearing aids · Mdhearingaid · Aug 4, 2022
K223137 — Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application · Hearx SA (Pty) , Ltd. · Mar 14, 2023
DEN180026 — Bose Hearing Aid · Bose Corporation · Oct 5, 2018
K231550 — Sontro® OTC Hearing Aids (AI) · Soundwave Hearing, LLC · Oct 26, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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. October 17, 2023 Intricon Corporation David Akbari Senior Medical Science, Clinical and Regulatory Affairs Liaison 1260 Red Fox Road Arden Hills, Minnesota 55112 Re: K223911 Trade/Device Name: Lumen 155-SF Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QUH Dated: August 31, 2023 Received: September 15, 2023 Dear Dr. Akbari: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) Device Name Lumen 155-SF Indications for Use (Describe) The Lumen® 155-SF self-fitting, wireless air conduction hearing aids are 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 over-thecounter sales without the assistance of a hearing health 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of colored dots in shades of blue, green, and gray on the left side. To the right of the dots is the company name, "Intricon," in gray lettering, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath. ## 510K Summary For Device The 510(k) Summary is provided on the following pages as required by 21 CFR 807.92(c). #### 1. SUBMITTER INFORMATION | Company Name: | Intricon Inc. | |------------------|-------------------------------------------------------------------------------------| | Company Address: | 1260 Red Fox Road Arden Hills, MN 55112 | | Company Contact: | David Akbari, Senior Medical Science, Clinical and Regulatory Affairs Liaison | | Email: | dakbari@intricon.com | | Phone/Fax: | 651-587-8347 | #### 2. DEVICE IDENTIFICATION | Trade Name: | Lumen 155-SF Self-Fitting Hearing Aids with Sentibo Application | |----------------------|--------------------------------------------------------------------| | Generic Device Name: | Hearing Aid | | Classification Name: | Self-Fitting, Air-Conduction Hearing Aid Over the Counter | | Regulation Class: | Class II | | Product Code: | QUH | | Assigned K-number: | K223911 | | Regulation Number: | 21 CFR 874.3325 | | Panel: | Ear, Nose and Throat Devices | #### 3. PREDICATE AND REFERENCE DEVICES Predicate Device: Nuheara IQbuds™ 2 PRO (K221064) Reference Devices: Bose Sound Control (K211008) Bose De Novo (DEN180026) The predicate and reference device(s) have not been subject to a design-related recall. #### 4. DEVICE DESCRIPTION Per 21 CFR 874.3325 a self-fitting wireless 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray text underneath. to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are class II medical devices. #### Device Characteristics The Lumen 155-SF self-fitting hearing aid(s) with Sentibo application is a self-fitting wireless air conduction Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software to be used on an Apple mobile device (mobile device not included) including wired lightning connector Apple EarPods for the assessment (not included) designed for a single user. The Sentibo app is available only on iOS. The Lumen 155-SF self-fitting OTC hearing aid(s) with Sentibo application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/open dome. The hearing aids can be fine-tuned by the user or remotely at the request of the user via the use of QR codes. Once the hearing aids are switched on, the software (Sentibo app) is required for the initial set-up, which is done via the smart phone and requires Apple EarPods with lightning connector to complete (not included). The Sentibo self-fitting software allows the consumer to self-select a hearing profile from a list of options by listening to digitized speech embedded in the software while scrolling through the hearing profiles in real-time through the Apple EarPods. After the setting is selected, the settings can be transferred from the smart phone to the hearing aid directly, though direct audio streaming from the smart phone to the hearing aid is unsupported with the Lumen 155-SF firmware. All Sentibo settings are stored in the application itself, and no internet service is required to perform the self-fitting. The Sentibo application provides 24 predefined options. At the conclusion of the assessment, the software will program hearing aids wirelessly and the user will wear the hearing aids per normal use. The smartphone app will function as a software accessory, allowing the user to make minor adjustments to the hearing aids. The hearing aid is intended to be used with the Sentibo App and to be worn and removed daily by the end user. #### Materials of Use The hearing aid makes long term/permanent contact with the skin in and around the ear. The body of the hearing aid rests on the outer shell of the ear (behind the ear) and is coupled to a dome via a slim tube that is worn inside of the ear canal. The materials used in the construction of the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application are biocompatible presenting no biological risk; thus, the requirements of ISO 10993-1 have been met. #### Key Performance Specifications The hearing aids are used with a replaceable, disposable, 1.45V, size 312 zinc air battery. The digital signal processing on the hearing aids allows for the following features to be adjustable: wide dynamic range compression, 16 frequency bands, noise reduction, feedback cancellation, wind noise suppression, low level expansion and microphone arrays (adaptive and fixed microphone directionality). #### 5. INTENDED USE/INDICATIONS FOR USE The Lumen® 155-SF self-fitting, wireless air conduction hearing aids are 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 over-the-counter sales without the assistance of a hearing care professional. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left, followed by the company name "Intricon" in gray text. Below the company name, the words "MICROMEDICAL TECHNOLOGY" are written in smaller gray text. The logo is simple and modern, and the use of circles suggests innovation and technology. ## 6. Labeling Self-Selection Labeling has been included in the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application product label and Instructions for Use (IFU) to mitigate the risk of improper self-selection. Summarized, it addresses the following: - Identifying situations in which the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application may help users hear better; - Identifying situations in which the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application may not be right for users. - Identifying criteria that indicate users should see a hearing professional. - - Informing users that the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with -Sentibo Application will not restore normal hearing. - -Informing users that it is good health practice to have hearing loss evaluated by a licensed healthcare professional. ## 7. Special Controls The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application conforms to the special controls stated in 21 CFR 874.3325. These requirements are satisfied through following: - Clinical Performance Validation - - -Non-clinical Performance Testing - Summative Usability/Human Factors Validation - - -Labeling ## 8. Comparison of Technological Characteristics with the Predicate The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application has the same intended use and fundamental technology as the predicate, Nuheara IQbuds 2 PRO (K221064). In the same manner as its predicate, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is 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 Sentibo application adds a unique element to the assessment by requiring the use of wired Apple EarPods with lightning connector terminus to perform the assessment, after which settings from the simulated model are transmitted to the hearing aid for use. The use of the Apple EarPods to perform the selfassessment and to transfer settings to the hearing aid has been electro-acoustically verified and performs similarly to the predicate device in terms of its measured acoustic output. The subject device is similar to the predicate in product design, dimension, use of Bluetooth technology and utilizing materials of high standard. The principles of operation of the subject device is explained as equivalent to the predicate. The subject device has no known biocompatibility issues, no known effect on the environment, or to other devices. At a high level, the subject and predicate devices are based on the following technological elements: - Self-fitting Air Conduction Hearing Aids - - Wireless Application via Bluetooth - - -On device controls - App (Sentibo Application) - {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the spiral is the company name, "Intricon," in a bold, sans-serif font, with the words "MICROMEDICAL TECHNOLOGY" in a smaller font underneath. - Software Platform Compatibility (iOS) - While both subject and predicate device both have the following elements at a high level, various differences in implementation exist such as the use of rechargeable versus replaceable batteries, and the device embodiment (behind the ear versus in the ear). These differences, where present, do not materially affect the safety or effectiveness of the device. - Batteries (Replaceable, disposable, 1.45 Volt, Size 312, Zinc Air, Batteries) - - Behind-The-Ear (BTE) - - Bi-directional Microphones - - User-Adjustable Tube Length Selection - - -Different size ear tips - Feedback Cancellation - - 16 Channel-wide Dynamic Input Compression - - Open Ear Tips in 3 sizes (Small, Medium, Large) - - 16 channel Noise Reduction - - -Requires wired Apple EarPods with lightning connector terminus Any differences between the subject and predicate device have been addressed through testing to a known performance standard. These differences are not significant and do not impact the effectiveness or safety of the subject device. The intended use and technological characteristics, (e.g., features, parameter settings etc) are similar to the predicate device (Nuheara IQbuds 2 PRO) cited above. The table below summarizes the characteristics of the Lumen 155-SF Hearing Aids in comparison to the predicate and, as applicable, one of the reference devices. The reference device Bose De Novo (DEN180026) serves a reference specific to the self-fitting strategy (i.e., self-administered hearing test and subsequently applied prescription) and clinical trial design, where the Bose Soundcontrol (K211008) is referenced because it uses the same self-fitting strategy as the Bose De Novo and represents a closer physical embodiment match to the subject device in that both are Behind The Ear (BTE) hearing aids. Since the Bose Soundcontrol is a closer physical match to the subject device, this specific reference device is referred to in the following table along with the predicate device as compared to the subject device for the purpose of demonstrating substantial equivalence. | Comparison of Subject and Predicate Devices | | | | | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject | Predicate | Reference | Discussion of Differences | | Device Trade Name | Lumen 155-SF | Nuheara IQbuds™ 2 PRO | Bose Sound Control | | | 510k Number | K223911 | K221064 | K211008 | | | Product Code | QUH | QUH | QDD | Same as predicate The over-the- counter (OTC) version of the self- fitting hearing aid has a different product code | | Regulation Number | 21 CFR 874.3325 | 21 CFR 874.3325 | 21 CFR 874.3325 | (QUH) to differentiate it from the direct-to- consumer (DTC) version (QDD) as used in the Bose Soundcontrol (K211008) reference device. | | Regulation Name | Self-fitting air conduction hearing aid | Self-fitting air conduction hearing aid | Self-fitting air conduction hearing aid, prescription | Same as predicate | | Intended Use | The Lumen 155-SF self-fitting, wireless air conduction hearing aids with Sentibo application are intended to amplify sound for adults 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 over-the-counter sales without the assistance of a hearing care professional. | The Nuheara IQbuds 2 PRO Hearing Aids are intended to amplify sound for individuals with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre- programming or hearing test is necessary. The device is intended for over the counter sale and use without the assistance of a hearing care | The Bose Hearing Aids are 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. No pre- programming or hearing test is necessary. The device is intended for direct-to- consumer sale and use without the assistance of a hearing care | Similar to predicate and reference Bose Soundcontrol (K211008) The clause "no pre-programming or hearing test is necessary" was omitted in the subject device as redundant in the context of a self- fitting hearing aid. | | Indications for Use | The Lumen 155-SF Hearing Aids are intended to amplify sound for adults 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for over-the-counter sales without the assistance of a | professional. The Nuheara IQbuds 2 PRO self-fitting hearing aids are intended to amplify sound for individuals 18 years and older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre- programming or hearing test is necessary. The | professional. The Bose SoundControl Hearing Aids are intended to amplify sound for adults 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre- programming or hearing test is necessary. The device is intended for direct-to- | Same as predicate and reference Bose Soundcontrol (K211008) | | | hearing care professional. | device is intended for over-the- counter sale and use without the assistance of a hearing care professional | for over-the- counter sales without the assistance of a hearing care professional. | | | Technology (batteries) | 312 zinc-air [non- rechargeable] hearing aid batteries | Rechargeable Lithium- ion polymer batteries | 312 zinc-air [non- rechargeable] hearing aid batteries | Same as reference Bose Soundcontrol (K211008) Subject device battery is non- rechargeable while the predicate is a rechargeable. The predicate Nuheara IQbuds 2 PRO (K211064) recharges by use of an AC plug adapter and connector to recharge, and cannot be used while charging. The subject device uses disposable zinc-air 312 batteries with drain noted in the ANSI S3.22 standard. The difference in batteries does not introduce new questions of safety as both devices meet the respective performance requirements for battery drain based on the technology used. | | Housing | Image: Behind-the-ear (BTE) | Image: In-the-ear (ITE) hearing aid | Image: Behind-the-ear (BTE) | Same as reference Bose Soundcontrol (K211008) Although the subject device hearing aid | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray dots on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray circles on the left, followed by the word "Intricon" in gray. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font. | | hearing aid housing. Separate left and right ear units (earbuds) with user control push buttons on each unit. Sold in pairs | housing. Separate left and right ear units (earbuds) with a separate Ear Tip for each unit. On device, 'Tap Touch' control to streaming audio and use with phone (via Bluetooth) Sold in pairs | hearing aid housing. Separate left and right ear units (earbuds) with user control push buttons on each unit. Sold in pairs | behind-the-ear style instead of an in-the-ear style, the difference in housing does not raise different questions of safety or effectiveness since both are tested to the same electroacoustic standards (ANSI/ASA S3.22 via reference in ANSI/CTA 2051). | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Input signal compression | Multichannel, wide dynamic range compression | Wide dynamic range compression | Multichannel, wide dynamic range compression | Same as reference Bose Soundcontrol (K211008) The subject, predicate, and reference devices all feature a form of wide dynamic range compression. The way in which frequency sub- divisions are used by the processing algorithm do not raise different questions of safety or effectiveness since both subject and predicate Nuheara IQbuds 2 PRO (K221064) devices are tested to the same electroacoustic standards. | | Microphones | Omnidirectional or Direction modes | Omnidirectional or Direction modes | Omnidirectional or Direction modes | Same as predicate and reference Bose Soundcontrol (K211008) | | Battery Life | 100 hours (312 zinc-air [non- rechargeable] hearing aid batteries) | Per CTA 2051 (4.1-4.17) Battery life of up to 8 hrs | 56 hours Up to 4 days, assuming 14hr day usage. (312 zinc-air [non- rechargeable] | Same as reference Bose Soundcontrol (K211008) | | | | | hearing aid batteries) | Battery drain differs between rechargeable and disposable batteries and does not raise any different issues of safety and effectiveness. | | Noise Reduction | The Lumen 155-SF features multi-layered adaptive noise reduction with selectable intensity (Low 7 dB, Medium 10 dB, High 13 dB, Max 17 dB) | Hybrid Active Noise Cancellation | Steady state noise reduction | The subject device performs in a similar manner to the predicate Nuheara IQbuds 2 PRO (K221064) and reference device Bose Soundcontrol (K211008) by reducing hearing aid output in response to detected noise signals. The method of detection and amount of gain reduction in response to environmental noise utilize different proprietary methodologies and were considered in context in the clinical data for the subject, predicate, and reference devices. The specific algorithm differences do not raise different issues of safety and effectiveness. | | Self-fitting method | User selects their preferred audio settings by listening to a smartphone using Apple lightning connector wired EarPods. Users audition their preferred settings based on predefined set of 24 options | Device uses a proprietary Ear ID, a validated NAL- NL2 fitting algorithm | Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL- NL2 | The predicate Nuheara IQbuds 2 PRO (K221064) device uses the NAL/NL2 self-fitting method which depends on the acquisition of pure tone audiometric thresholds, whereas the | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray dots on the left side. To the right of the dots is the company name "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in smaller gray letters. | | | subject device's functionally similar self-fitting method uses digitized human voice. The subject device's fitting method is adequate for fitting mild to moderate hearing loss, the same as prescribed by NAL- NL2. Sentibo OTC provides 24 predefined options. In the subject device, Apple EarPods are required while they are not required for either predicate Nuheara IQbuds 2 PRO (K221064) or reference devices. The subject device has been measured and validated in-situ to demonstrate that the EarPod presented running speech range is the basis by which the hearing aid also performs when used with its volume control and input-controlled compression. Because the subject device meets the same electroacoustic test standards as the predicate and reference devices, no different questions of safety or effectiveness are introduced despite the technological differences in fitting | |--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray text underneath. | Mobile App | Mobile application on a smart device (phone or tablet) with iOS platform | Mobile application on a smart device (phone or tablet) with either iOS or Android platforms | Mobile application on a smart device (phone or tablet) with either iOS or Android platforms | Similar to Predicate and Reference Device Bose Soundcontrol (K211008), except subject device is not compatible with Android platform | |-------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Remote firmware updates | Not supported | The subject device via the Nuheara app allows for remote firmware updates to the hearing aids. | The hearing aids update automatically when connected to the Bose Hear app. Follow the app instructions. | Subject device does not allow for remote firmware updates While the subject device does not support remote firmware updates and both the predicate Nuheara IQbuds 2 PRO (K221064) and reference device Bose Soundcontrol (K211008) do, the subject, predicate, and reference device all conform to similar wireless recognized consensus standards. Since the subject device does not allow the potential for firmware modification wirelessly, no new questions of safety or effectiveness are introduced. | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller font. ## Electro-Acoustic Characteristics per ANSI/ASA S3.22 and ANSI/CTA 2051:2017 (and ANSI/ASA S3.22 by reference) | | Subject | Predicate | Reference | Discussion of Differences | |------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name | Lumen 155-SF | Nuheara IQbuds™ 2 PRO | Bose Sound Control | Same as predicate Nuheara IQbuds 2 PRO (K221064) within measurement uncertainty tolerance. The subject, predicate, and reference Bose Soundcontrol (K211008) devices all have programmable latency, and all are less than or equal to 15 ms as specified in ANSI/CTA 2051. | | 510k Number | K223911 | K221064 | K211008 | | | Latency clause 4.8 | 5.8 ms | 5 ms | 5.5 ms | | | Frequency response | < 200 Hz - 8000 Hz | 200 Hz - 8000 Hz | < 200 — 8000 Hz | The subject device meets the requirements, same as the predicate. | | Input distortion clause 4.4.2 | Less than or equal to 5% (measure is 1.2%) | Less than or equal to 5% (measure is 0.7%) | Less than or equal to 5% | The subject device meets the requirements, same as the predicate. | | Equivalent Input Noise (EIN) (Self-generated Noise Levels) Clause 6.12 | 26.4 dB SPL | 28.5 dB SPL | < 23 dB SPL typical, < 27 dB SPL max | The subject device meets the requirements, same as the predicate. | | Harmonic Distortion Clause 6.11 | <0.5% typical, <1% max | 0.2% | < 0.5% typical, < 1% max | The subject device meets the requirements, same as the predicate. The results describing "typical" and "max" are from repeated measures on multiple units in order to confirm the values as it relates | | | | | | | | | | | | to the ANSI/ASA S3.22 test for harmonic distortion. The difference between the slim tube embodiment of the subject device and the ITE embodiment of the reference device will result in slightly different values between the units, but both devices meet the same electroacoustic requirements. | | Max OSPL90 Clause 6.2 | 114.4 dB SPL | 109.6 dB SPL | 113 dB SPL | The subject device meets the requirements, same as the predicate. The subject, predicate Nuheara IQbuds 2 PRO (K221064), and reference device Bose Soundcontrol (K211008) feature output limiting and input-controlled compression and show OSPL90 values that are less than the maximum allowable 117 dB SPL limit. | | HFA OSPL90 Clause 6.3 | 109.6 dB SPL | 100.9 dB SPL | 106 dB SPL | The subject device meets the requirements, same as the predicate. | | HFA FOG Clause 6.5 | 51 dB | 29.4 dB SPL | 30 dB | The subject device will provide more amplification for soft sound inputs. No specific gain limit was identified or required in the final OTC rule. While higher than the predicate Nuheara IQbuds 2 PRO (K221064) and reference Bose Soundcontrol | | | | | | | | | | | (K211008) devices, device gain is dependent on the input. Since the subject device features output limiting which is always enabled, no different questions of safety or efficacy are introduced as a result of this difference. | | | Reference Test Gain (RTG) Clause 6.7 | 45 dB | 24.4 dB SPL | 29 dB | The subject device meets the requirements, same as the predicate Nuheara IQbuds 2 PRO (K221064). Reference Test Gain is descriptive only according to ANSI/ASA S3.22. Where differences between the subject device and predicate device exist, no different questions of safety or efficacy are introduced. | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the spiral is the company name, "Intricon," in gray text, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray text underneath. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo for Intricon, a micro medical technology company. The logo consists of a circular pattern of blue, green, and gray dots on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font. The logo is clean and modern, and the use of color suggests innovation and technology. #### 9. NON-CLINICAL PERFORMANCE DATA The subject device was tested for conformity to the following FDA recognized consensus standards applicable to the self-fitting hearing aid for its intended use. Biocompatibility - ISO 10993-1 Biological evaluation of medical devices ● - ISO 10993-12 Biological evaluation of medical devices - ISO 10993-5 Biological evaluation of medical devices ● - ISO 10993-10 Biological evaluation of medical devices ● #### Electro-Acoustics - ANSI/ASA S3.22 2014 (R2020) Measurements ● - . ANSI/CTA 2051 2017 In order to establish substantial equivalence to the predicate device. Intricon evaluated the electroacoustic data as found in the predicate and required under Special Controls for 21 CFR §874.3325. As seen in the Electroacoustic Characteristics per ANSI S3.22 and CTA 2051:2017 table above, the measurement for the specific cited clauses indicates that the Lumen 155-SF hearing aid(s) with Sentibo application are {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles i…

Lumen 155-SF

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Lumen 155-SF

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