MODEL C-1 HEARING AID by BETTER HEARING, INC.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Other Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other 1. Low tolerance To Loudness

Device Description

BETTER HEARING, INC. model C-1 Hearing Aid, Type: Behind-The-Ear (BTE), Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery

AI/ML Overview

This document is a 510(k) summary for the BETTER HEARING, INC. Model C-1 Hearing Aid. It confirms substantial equivalence to other devices rather than presenting a study to prove meeting acceptance criteria in the way a clinical trial for a novel device would. Therefore, most of the requested fields are not applicable (N/A) as this is a premarket notification for a Class I device and not a clinical study report.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantially Equivalent to Predicate Device	Confirmed as "substantially equivalent" to “other medium power compression BTE hearing aids”.
Meets ANSI S3.22 1987 Standard	"Hearing Aid has been tested per ANSI S3.22 1987."
Fits Mild to Moderate Hearing Losses	"Fits: Mild to moderate hearing losses."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: N/A (No specific test set or clinical study described in detail for performance evaluation beyond compliance with a standard.)
Data Provenance: N/A (The document focuses on regulatory compliance and substantial equivalence, not a clinical study with geographic or temporal data origin.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A (No ground truth established by experts for a test set is discussed in this regulatory summary.)

4. Adjudication method for the test set

N/A (No test set or adjudication method is described.)

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A (This device is a hearing aid, not an AI-powered diagnostic device. No MRMC study was performed.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A (Not an AI algorithm.)

7. The type of ground truth used

N/A (The "ground truth" here is the regulatory standard of substantial equivalence and compliance with ANSI S3.22 1987, rather than a clinical ground truth for a diagnostic task.)

8. The sample size for the training set

N/A (Not an AI device; no training set in the AI sense.)

9. How the ground truth for the training set was established

N/A (Not an AI device; no training set in the AI sense.)

Summary

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K913043

BETTER HEARING, INC. 112 ELDEN ST. (703) 709-7021 FAX: -9565 HERNDON, VIRGINIA 20170-4809 Our 5th anniversary: 1992 - 1997

OCT 2 7 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name: BETTER HEARING, INC. model C-1 Hearing Aid

Type: Behind-The-Ear (BTE)

Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300.

Intended Use: To amplify and transmit sound to the ear.

Substantially Equivalent to: Other medium power compression BTE hearing aids.

Registration Number: Applied for on April 4, 1997

Materials: Manufactured from materials commonly used in the industry.

Technical Characteristics: Hearing Aid has been tested per ANSI S3.22 1987.

Fits: Mild to moderate hearing losses.

Power: Size 675 Battery

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1997

Louis T. Gnecco Vice President Better Hearing, Inc. 112 Elden Street Herndon, VA 20170-4809 Re: K973043 Better Hearing, Inc. Model C-1 Air Conduction Hearing Aid Dated: August 11, 1997 Received: August 15, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Gnecco:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary. . . . . . . . . . . .

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Xia, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):_

BETTER HEARING INC. Model < - | Hearing Air

Device Name:

Indications For Use:

A. General Indications:

Severity:

Other Configuration: l. Low tolerance l. Slight l. High Frequency To Loudness - Precipitously Sloping 2. Mild 2. Gradually Sloping 2. 3. Reverse Slope 3. Moderate 4. Severe . Flat 5. Profound 5. Other

B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IP HEEDED)

Concurrence of CDBA/ Office of Device Evaluation (ODE)

Uhind Co. Seymon
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De

510(k) Number K973043

Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

Regulation Number and Section

§ 874.3300 Air-conduction hearing aid.

(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.