Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
The Hearing Aid, Air-Conduction with Wireless Technology, Over The Counter is a wearable sound-amplifying device for hearing compensation that incorporates wireless technology for programming or functional use, available directly to consumers without a prescription under the 2022 OTC Hearing Aid final rule (87 FR 50698). The wireless functionality enables Bluetooth connectivity and remote programming capabilities. Classified as FDA Class 2 under regulation 874.3305, it requires 510(k) clearance in the Ear, Nose, and Throat specialty, reflecting the additional considerations of wireless technology. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QUG
- 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 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.
FEI Numbers
This FDA classification entry is associated with 88 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 88 registration numbers. Click on an entry to view related FDA registrations.