(107 days)
To amplify and transmit sound to the ear. 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): Severity: Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Other. Other: Low tolerance To Loudness.
BETTER HEARING, INC. model L-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.
Based on the provided text, the "Better Hearing, Inc. Model L-1 Hearing Aid" is a relatively simple device, and the submission document primarily focuses on its substantial equivalence to existing devices rather than a detailed study for novel performance claims. Therefore, much of the requested information (like expert ground truth, MRMC studies, training set details) is not applicable or not provided.
Here's an analysis of the available information:
Description of the Device and its Primary Claim:
The device is a "Behind-The-Ear (BTE)" hearing aid whose "Intended Use: To amplify and transmit sound to the ear." Its classification is "Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300."
A specific claim made by the manufacturer was its "compatibility with digital cellular telephones."
Acceptance Criteria and Reported Device Performance
The FDA did not accept the claim of compatibility with digital cellular telephones. Therefore, there are no reported device performance metrics for this specific claim that met acceptance criteria in this document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Functionality: Amplify and transmit sound to the ear. | "Hearing Aid has been tested per ANSI S3.22 1987." This standard likely covers basic acoustic performance (gain, frequency response, output). Specific numerical performance values are not provided in this document but are implied to have met the standard. |
| Substantial Equivalence: To other medium power linear BTE hearing aids. | Determined to be substantially equivalent by the FDA for its primary function as a hearing aid. |
| Compatibility with digital cellular telephones. | NOT ACCEPTED by FDA. "While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that the claim regarding electromagnetic compatibility with digital cellular telephones has not been adequately substantiated and cannot be permitted at this time. Based upon inadequate EMC test data submitted in this 510(k), use of such a claim may result in the device being misbranded." |
Study Details Related to the "Compatibility with digital cellular telephones" Claim:
The FDA explicitly states that "inadequate EMC test data" was submitted for this claim. This implies some testing was done by the manufacturer, but it did not meet the FDA's criteria for substantiation.
Since the claim was rejected, the following details pertain to the unaccepted study or data:
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "inadequate EMC test data," suggesting internal testing by the manufacturer.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. For an EMC claim, ground truth would typically be established by standardized measurement protocols rather than expert consensus on subjective interpretation.
- Adjudication method for the test set: Not applicable/not specified. EMC testing would involve objective measurements against a standard, not expert adjudication in the typical sense.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for an electromagnetic compatibility claim.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. EMC testing is a standalone objective measurement of the device's interaction with electromagnetic fields.
- The type of ground truth used: Implied to be objective measurements against an electromagnetic compatibility standard (though the specific standard, beyond "inadequate EMC test data," is not detailed).
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
Summary of FDA's Position:
The FDA determined the Model L-1 Hearing Aid was substantially equivalent to predicate devices for its primary function as a hearing aid. However, its specific claim of "compatibility with digital cellular telephones" was not accepted due to insufficient data. The FDA offered to work with Better Hearing, Inc. to develop a testing protocol to substantiate an appropriate claim for EMC.
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Public Health Service
JUL 2 3 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Louis T. Gnecco, M.S.E.E. Vice President Better Hearing, Inc. l 12 Elden Street Herndon, VA 20170-4809 Re: K971298 Better Hearing, Inc. Model L-1 Hearing Aid Dated: June 28, 1997 Received: July 8, 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 Ouality System Regulation (OS) 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 iegally marketed hearing alds, please be advised that the claim regarding clectromagnetic compatibility with digital cellular telephones has not been adequately substantiated and cannot be permitted at this time. Based upon inadequate EMC test data submitted in this 510(k), use of such a claim may result in the device being misbranded.
We would be pleased to work with you regarding the development of a testing protocol to substantiate an appropriate claim. We will include this subject as an agenda item for our upcoming meeting on July 24.
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Page 2 - Mr. Louis Gnecco
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".
We look forward to meeting with you in the spirit of understanding and cooperation.
Sincerely yours,
David U. beyers
for William H. Rice, 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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JUL 23 1997
SU. SA
BETTER HEARING, INC. Mr. H. Sauberman, FDA: June 28, 1997 Enclosure 3:
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name: BETTER HEARING, INC. model L-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 linear BTE hearing aids. Differs in that it is compatible with digital collular telephones
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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| 510(k) Number (if known): | APPLIED FOR: APR 4,1997 | |
|---|---|---|
| Device Name: | BETTER HEARING INC. Model L-1 Hearing Aid | |
| Indications For Use: | ||
| A. General Indications: | ||
| 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: | Configuration: | Other |
| 1. Slight | 1. High Frequency- Precipitously Sloping | 1. Low tolerance To Loudness |
| 2. Mild | 2. Gradually Sloping | 2. |
| 3. Moderate | 3. Reverse Slope | 3. |
| 4. Severe | 4. 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.) | ||
| 1. Compatible with digital cellular telephones.See SE letter7/20/97 JHC | ||
| 2. | ||
| 3. |
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number K971298 |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
§ 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.