| Device |
self-fitting air-conduction hearing aid, over the counter |
| Regulation Description |
Self-fitting air-conduction hearing aid. |
| Definition |
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf. |
| Physical State |
The self-fitting air-conduction hearing aid consists of the following components that are worn on the body, typically at ear level: microphone, receiver, and signal processor. In addition, the device will have a user interface for adjusting the hearing aid. |
| Technical Method |
A self-fitting air-conduction hearing aid incorporates technology, including software, used by the listener to configure parameters, settings, and listening modes to meet the user's listening needs. |
| Target Area |
The self-fitting air-conduction hearing aid provides amplification to the ear. |
| Regulation Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | QUH |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
874.3325
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
