Hearing Aid, Air-Conduction With Wireless Technology, Prescription
The Hearing Aid, Air-Conduction with Wireless Technology, Prescription (product code OSM) is a wearable sound-amplifying device intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. It is a prescription hearing aid requiring a healthcare professional's involvement in fitting and adjustment. As an FDA Class 2 device under regulation 874.3305, it requires 510(k) premarket clearance and falls within the Ear, Nose, Throat specialty. The device is not an implant and is not life-sustaining.
Research product code OSM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OSM
- Device Class
- FDA class 2
- Regulation Number
- 874.3305
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
Definition
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN100025 | WIDEXLINK IN CLEAR SERIES HEARING AIDS | Mar 31, 2011 | Unknown | Office Research IN Clinical Amplifiction |
FEI Numbers
This FDA classification entry is associated with 76 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 76 registration numbers. Click on an entry to view related FDA registrations.