(21 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 ability. These 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 Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other 1. Low tolerance To Loudness ✓ 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.
Not Found
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study proving a device meets these criteria based on the provided text. The documents you've supplied are an FDA 510(k) clearance letter and an "Indications For Use" statement for the "Oticon DigiSound Compact" hearing aid from 1997.
These documents do not contain the detailed information you've requested, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study details, including effect size.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes, etc.).
- Sample size for training sets or how ground truth for training was established.
The FDA 510(k) clearance process, especially in 1997, for a hearing aid of this nature, primarily focused on substantial equivalence to existing predicate devices. This means the manufacturer demonstrated that their device was as safe and effective as a legally marketed device, often through engineering and performance testing rather than extensive clinical efficacy studies with the types of details you're asking for in the context of AI/ML performance.
The provided text only confirms that the device was found substantially equivalent and lists its general and specific indications for use, primarily relating to types and severities of hearing loss.
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Image /page/0/Picture/0 description: The image shows a black and white seal for the Department of Health & Human Services USA. The seal features the department's emblem, which consists of a stylized caduceus-like symbol with three curved lines, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Proben Brunved Oticon, Inc. 29 Schoolhouse Rd. Somerset. NJ 08873 Re:
K973886 Oticon DigiSound Compact Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD NOV - 4 1997
Dear Mr. Brunved:
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, 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 (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 (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 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.
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,
William Yu, 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): _
Device Name: DigiSound Compact
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this the indication for abily sound for individuals with impaired Submission 13 co capices 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 | |
| Configuration: | |
| 1. High Frequency - Precipitously Sloping | ✓ |
| 2. Gradually Sloping | ✓ |
| 3. Reverse Slope | ✓ |
| 4. Flat | ✓ |
| 5. Other | |
| Other | |
| 1. Low tolerance To Loudness | ✓ |
| 2. | |
| 3. |
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
-
To amplify and deliver sound to the ear via air conduction
(PLEASE DO HOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HELDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ylavid le. de form
Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number
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.