K Number

Device Name

BHA100 Series Braun Clear Hearing Aid

Manufacturer

Kaz USA, Inc., a Helen of Troy Company

Date Cleared

2022-01-05

(141 days)

Product Code

QDD

Regulation Number

874.3325

Intended Use

The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid, intended to amplify sound for individuals 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. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.

Device Description

The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid. It features digital signal processing (16 channel-wide dynamic input compression, 3 channel fast-acting output compression, 16 channel noise reduction, feedback cancellation,) bi-directional microphone with windscreen, volume and program control (environment selection - Quiet, Noisy, Concert, TV), 3 channel equalizer, self-adjustable wire and ear tips, and customization through the Braun® Clear™ Mobile Application. The Braun® ClearCheck™ Hearing Test aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Braun® Clear™ Hearing Aid. These thresholds are used to program the device using a proprietary fitting algorithm.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K211008

Reference Devices

K151025

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "digital signal processing" and a "proprietary fitting algorithm," but does not explicitly mention AI or ML, nor does it provide details about training or test sets which are common indicators of ML use.

Therapeutic

Yes

The device is a self-fitting hearing aid intended to amplify sound for individuals with hearing impairment, aiming to alleviate or compensate for a condition, thus making it a therapeutic device.

Diagnostic

Yes

Explanation: The "Braun® ClearCheck™ Hearing Test aims to detect accurate auditory thresholds," which indicates it performs a diagnostic function to assess hearing impairment. These thresholds are then used to program the device, demonstrating that the device integrates a diagnostic component for user-customized sound.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a bi-directional microphone, volume and program control, and self-adjustable wire and ear tips, in addition to the mobile application software.

IVD (In Vitro Diagnostic)

Based on the provided information, the BHA100 Series Braun® Clear™ Hearing Aid is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is a hearing aid that amplifies sound for individuals with perceived hearing impairment. It works by processing sound from the environment and delivering it to the user's ear. It does not analyze any biological samples (like blood, urine, tissue, etc.).
The "Braun® ClearCheck™ Hearing Test" component, while involving a test, is a functional test of hearing ability, not an analysis of a biological specimen. It aims to detect auditory thresholds, which is a measure of how well a person hears at different frequencies. This is a physiological measurement, not an in vitro diagnostic test.

Therefore, the BHA100 Series Braun® Clear™ Hearing Aid falls under the category of a medical device, specifically a hearing aid, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

QDD

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

18 years of age or older

Intended User / Care Setting

direct-to-consumer sale and use without the assistance of a hearing health care professional.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The pivotal clinical study of the BHA100 Series Braun® Clear™ Hearing Aid was a prospective, randomized, two-arm, multicenter (4 clinical sites) clinical validation study. The study was conducted among a population of 80 adults.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Results:
Phase 1 Primary Endpoint: The primary endpoint of Phase 1 was the mean absolute difference (MAD) between the Pure Tone Average (PTA), across all frequencies, of subject hearing loss in dB from the self-fitting hearing test, performed by a subject using the Braun® Clear™ mobile application in an audiometric sound booth, and the PTA of subject hearing loss in dB from the audiologist executed hearing test, each performed in an audiometric sound booth. The MAD was 2.8 dB, with a 95% Confidence Interval of 2.4 dB to 3.2 dB and p

Regulation Number and Section

§ 874.3325 Self-fitting air-conduction hearing aid.

(a)
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.(b)
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.

Summary

Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 5, 2022

Kaz USA, Inc., a Helen of Troy Company Matt Baun Director of Clinical & Regulatory Affairs 400 Donald Lynch Boulevard, Suite 300 Marlborough, Massachusetts 01752

Re: K212609

Trade/Device Name: BHA100 Series Braun Clear Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QDD Dated: December 1, 2021 Received: December 6, 2021

Dear Matt Baun:

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 announce ments 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

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,

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

Indications for Use

510(k) Number (if known) K212609

Device Name BHA100 Series Braun® Clear™ Hearing Aid

Indications for Use (Describe)

Restricted Device (per 21 CFR 801.420 and CFR 801.421).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

. SUBMITTER

Kaz USA, Inc., a Helen of Troy Company 400 Donald Lynch Blvd., Suite 300 Marlborough, MA 01752 Establishment Registration Number: 3006169981 Contact Person: Matt J. Baun, Director of Clinical & Regulatory Affairs Phone: (508) 490-7240 E-mail: MBaun@helenoftrov.com Date Prepared: 10-August-2021

SUBJECT DEVICE II.

Trade / Device Name: BHA100 Series Braun® Clear™ Hearing Aid Requlation Number: 21 CFR 874.3325 Regulation Medical Specialty / 510k Review Panel: Ear Nose & Throat Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QDD 510(k) number: K212609

lll. PREDICATE DEVICE

Bose SoundControl™ Hearing Aids - 510(k) # K211008

IV. REFERENCE DEVICE

iHearTest - 510(k) # K151025

V. DEVICE DESCRIPTION

VI. INTENDED USE / INDICATIONS FOR USE

VII. LABELING

Self-Selection Labeling has been included in the BHA100 Series Braun® Clear™ Hearing Aid Owner's Manual (OM) / Instructions for Use (IFU) to mitigate the risk of improper self-selection. Summarized, it addresses the following:

ldentifying situations in which the BHA100 Series Braun® Clear™ Hearing Aid may help users hear ● better.
ldentifying situations in which the BHA100 Series Braun® Clear™ Hearing Aid may not be right for users. ●
Identifying criteria that indicate users should see a hearing professional.
Informing users that the BHA100 Series Braun® Clear™ Hearing Aid will not restore normal hearing. .
Informing users that it is qood health practice to have hearing loss evaluated by a licensed healthcare ● professional.

VIII. SPECIAL CONTROLS

The BHA100 Series Braun® Clear™ 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 ●

IX. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATEDEVICE

Both the subject device, the BHA100 Series Braun® Clear™ Hearing Aid, and the predicate device, the Bose SoundControl™ Hearing Aids (510(k) # K211008), are self-fitting, direct-to-consumer, hearing aids indicated for individuals 18 and 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.

Both devices contain the following, similar technological characteristics:

Self-Fitting Hearing Aid ●
Home Healthcare Environment Use
Bluetooth
On Device Controls ●
App (Braun® Clear™ App) ●
Software Platform Compatibility (iOS, Android) ●
Replaceable, Disposable, 1.45 Volt, Size 312, Zinc Air, Hearing Aid Battery Power Source
Traditional, Receiver-In-Canal (RIC) / Behind-The-Ear (BTE) Form Factor ●
Bi-directional Microphones ●
User-Adjustable Wire ●
Different Size Ear Tips

The BHA100 Series Braun® Clear™ Hearing Aid includes:

16-Channel Noise Reduction
. Feedback Cancellation
16-Channel Wide Dynamic Input Compression ●
3-Channel Fast-Acting Output Compression ●
3-Channel Equalizer (Low / Mid / High)
Open and Closed Ear Tips in 3 Sizes (Small, Medium, Large) .

Any differences in technological characteristics between the subject and predicate device have been addressed through testing to a known performance standard or by showing equivalency in terms of function. Therefore, these differences are not significant and do not change the safety or effectiveness of the subject device.

X. CLINICAL PERFORMANCE TESTING

Study Design

The pivotal clinical study of the BHA100 Series Braun® Clear™ Hearing Aid was a prospective, randomized, two-arm, multicenter (4 clinical sites) clinical validation study. In Phase 1 of the study, the safety and effectiveness of the self-fitting hearing test of the BHA100 Series Braun® Clear™ Hearing Aid was evaluated through quantitative measures (audiometric thresholds and REM) while comparing it to fitting of the same hearing aid by a licensed audiologist using a calibrated, clinical audiometer. In Phase 2 of the study, subjects were randomized 1:1 into the 2 fitting strategies and completed a 60-day field trial in either the "Audiologist Fit" group (audiologist fit only, with no ability to take the self-fitting hearing test, as would be the case for a typical, professionally-fit hearing aid) or a "Self-Fit" group (no access to audiologist fit, self-fit completed through the Braun® Clear™ Mobile Application and re-fitting with the Braun® ClearCheck™ Hearing Test enabled). During this phase, the safety and effectiveness of the whole BHA100 Series Braun® Clear™ Hearing Aid System (hearing aid and mobile application) was evaluated through qualitative measures (the Client-Oriented Scale of Improvement, a series of questionnaires assessing the benefit associated with the hearing aid to the individual user).

Subject Demographics

The study was conducted among a population of 80 adults. Table 1 below, provides information on the total study population and Table 2 provides information on subject demographics by cohort ("Audiologist-Fit" / "Self-Fit") of the study.

Characteristic	N / Total (%)
Age
18 to 40 years of age	5 / 80 (6.25%)
41 to 50 years of age	2 / 80 (2.5%)
51 to 60 years of age	18 / 80 (22.5%)
61 to 70 years of age	36 / 80 (45.0%)
71 to 90 years of age	18 / 80 (22.5%)
81 to 90 years of age	1 / 80 (1.25%)
Sex
Female	44 / 80 (45.3%)
Male	36 / 80 (54.7%)
Baseline hearing loss duration (as reported by the subject)
Have no hearing loss	5 / 80 (6.3%)
Have recently emerged hearing impairment (less than 1 year ago)	11 / 80 (13.8%)
Have had hearing loss for 1 year or longer	64 / 80 (80.0%)
Baseline hearing loss severity (tested by audiologist, based on worse ear)
No hearing loss	3 / 80 (3.75%)
Mild hearing loss	34 / 80 (42.5%)
Moderate hearing loss	33 / 80 (41.25%)
Severe hearing loss	10 / 80 (12.5%)
Hearing Loss Type
Conductive	0 / 80 (0%)
Sensorineural	80 / 80 (100%)
Mixed	0 / 80 (0%)
Hearing aid use (as reported by the subject)
Experienced User	27 / 80 (33.8%)
New User	53 / 80 (66.3%)

Table 2 – Subject Demographics: By Cohort

Demographic Category	All Subjects
	Audiologist-Fit	Self-Fit
Sample Size	40	40
6 Frequency PTA* (dB HL) (Mean, STD)	38.1, 11.9	38.4, 14.5
Sensorineural Hearing Loss† (# of subjects)	40	40
Conductive Hearing Loss† (# of subjects)	0	0
Mixed Hearing Loss† (# of subjects)	0	0
No Hearing Loss (# of subjects)	2	1
Mild Hearing Loss (# of subjects)	15	19
Moderate Hearing Loss (# of subjects)	18	15
Severe Hearing Loss (# of subjects)	5	5
Asymmetric Hearing Loss‡ (# of subjects)	3	5
New Hearing Aid Users (# of subjects)	26	27
Experienced Hearing Aid Users (# of subjects)	14	13
Age (Years) (Mean, STD)	63.9, 12.4	63.1, 11.6
Sex (Female, Male)	21, 19	24, 16

Thresholds measured at 250 Hz, 500 Hz, 1000 Hz, 4000 Hz, and 6000 Hz (Figure 2a and Figure 2b)

† Conductive component if Air Bone Gap ≥ 15 dB HL at 500, 1000, 2000, and 4000 Hz

Defined as a difference in PTA that is greater than 15 dB between ears (American Academy of Otolaryngology—Head and Neck Surgery)

Study Procedures

The study was divided into 2 phases. The objective of Phase 1 was to validate the effectiveness of the self-fitting hearing test of the BHA100 Series Braun® Clear™ Hearing Aid, while the objective of Phase 2 was to demonstrate the effectiveness of the whole BHA100 Series Braun® Clear™ Hearing Aid System (the hearing aid and mobile application).

Phase 1 of the study evaluated the BHA100 Series Braun® Clear™ Hearing Aid through quantitative measures during a single, initial, "Baseline" clinic visit. As direct comparison to the Bose SoundControl™ Hearing Aids (510(k) # K211008) was not possible, due to them not being available at the time of the study, the BHA100 Series Braun® Clear™ Hearing Aid was compared to fitting of the same hearing aid by a licensed audiologist using a calibrated, clinical audiometer. All 80 subjects performed both selffitting of the BHA100 Series Braun® Clear™ Hearing Aid and underwent clinical audiometry to determine their audiometric thresholds, which could then be programmed into the hearing aids, as needed. All 80 subjects underwent Real Ear Measures (REM) while wearing the BHA100 Series Braun® Clear™ Hearing Aid using both their self-fitting thresholds, and the audiologist determined thresholds.

Phase 2 of the study evaluated the BHA100 Series Braun® Clear™ Hearing Aid System through qualitative measures over the course of four (4) clinic visits ("Baseline", "14 ± 3 days", and "60 ± 3 days"). All 80 subjects completed Client Oriented Scale of Improvement (COSI) baseline (unaided) questionnaires and were then sent home for 60 days of field use with the BHA100 Series Braun® Clear™ Hearing Aid, randomized (1:1) to either the "Audiologist-Fit" or "Self-Fit" fitting strategies. COSI questionnaires were completed at each of the remaining 3 clinic visits to assess the improvement of listening / hearing goal achievement (participant-set goals) at 60 days from baseline values. The COSI was assessed on ability to achieve improvement (based on participant-reported, and compared between self-fitting and audiologist-led fitting groups.

Figure 1 below, depicts the experiment timeline for the pivotal clinical study of the BHA 100 Series Braun® Clear™ Hearing Aid.

Image /page/6/Figure/5 description: The image is a diagram of an experiment timeline. The timeline starts with a baseline clinic visit, followed by randomization. The timeline then splits into two paths, one labeled "Audiologist-Fit" and the other labeled "Self-Fit". Both paths lead to three clinic visits, labeled #1, #2, and #3, which occur at 14 ± 3 days, 30 ± 3 days, and 60 ± 3 days, respectively. The field use is an average of 59.1 days.

Figure 1 - Experiment Timeline

Study Results

Phase 1 Primary Endpoint:

The primary endpoint of Phase 1 was the mean absolute difference (MAD) between the Pure Tone Average (PTA), across all frequencies, of subject hearing loss in dB from the self-fitting hearing test, performed by a subject using the Braun® Clear™ mobile application in an audiometric sound booth, and the PTA of subject hearing loss in dB from the audiologist executed hearing test, each performed in an audiometric sound booth.

The MAD was 2.8 dB, with a 95% Confidence Interval of 2.4 dB to 3.2 dB and p