(107 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies reference standard hearing aid technology and testing methods (ANSI S3.22 1987).
No.
The device is a hearing aid used to amplify sound for individuals with impaired hearing, which is a compensatory device rather than a therapeutic one seeking to treat or cure a condition.
No
The device is described as an "Air Conduction Hearing Aid" which amplifies and transmits sound to the ear for individuals with impaired hearing. Its purpose is to correct a hearing impairment, not to diagnose one.
No
The device description explicitly states it is a "Behind-The-Ear (BTE)" hearing aid and mentions a "Size 675 Battery," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify and transmit sound to the ear" for individuals with impaired hearing. This is a functional device that interacts with the body to improve hearing, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description clearly identifies it as an "Air Conduction Hearing Aid," which is a type of medical device used for hearing assistance, not for in vitro diagnostic testing.
- Classification: It is classified as "Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300," which falls under regulations for hearing aids, not IVDs.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
This device is a hearing aid, which is a medical device used to treat hearing loss, not an IVD.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
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:
4. Severe
5. Profound
Configuration:
- High Frequency
- Precipitously Sloping
- Other
Other
- Low tolerance To Loudness
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
Type: Behind-The-Ear (BTE)
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
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
3
| 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 letter
7/20/97 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)