(30 days)
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)): Serverity: 1. Slight 2. Mild X 3. Moderate X 4. Severe X 5. Profound Configuration: 1. High Frequency - Precipitously sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low tolerance to loudness 2. 3. B. Specific Indications (Only if appropriate.): 1. psychoacoustic indications such as improved speech (Most intelligibility in background noise, must be supported by clinical data.) 2. 3.
RION HB-79P
The provided document is a 510(k) clearance letter for the Rionet HB-79P hearing aid. It is a regulatory document affirming substantial equivalence to a predicate device, rather than a study report detailing performance against acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details of a standalone algorithm-only performance study.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
The document indicates that the device's indication for use is "to amplify sound for individuals with impaired hearing" within specific severity and configuration categories of hearing loss (e.g., Moderate, Severe, Profound, Gradually Sloping, Reverse Slope, Flat). However, these are indications for use and not performance acceptance criteria against which a study measured the device. The only mention of "clinical data" is for "psychoacoustic indications such as improved speech intelligibility in background noise," but no such data or study is presented or summarized in this regulatory letter.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the head and body of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN - 6 1997
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Henry C. Smith President . . Authorized Hearing Systems, Inc. 806 Beaver Street Bristol, PA 19007
Re: K971693 Rionet HB-79P ............ Dated: April 16, 1997 Received: May 7, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
14 Dear Mr. Smith:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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10(k) Number (if known): K971693 Device Name: ___RION HB-79P
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)):
| Serverity: | Configuration: | Other: |
|---|---|---|
| 1. Slight | 1. High Frequency - Precipitously sloping | 1. Low tolerance to loudness |
| 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | 3. |
| X 4. Severe | X 4. Flat | |
| X 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.):
psychoacoustic indications such as improved speech (Most intelligibility in background noise, must be supported by clinical data.)
3 .
Gland A. Stgem
(Division Sign-Off)
Reproductive, Abdominal, EN
§ 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.