Consulting Wallah › Device Explorer › Hearing & audiology › Air-conduction hearing aid, receiver-in-canal
Device Explorer · FDA GUDID · GMDN 47169

Air-conduction hearing aid, receiver-in-canal

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (sp

US‑registered devices15,482in commercial distribution
Companies25labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription33%Rx‑only share
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Share of device records

Widex A/S3,09220%
Gn Hearing A/S2,67517%
Ws Audiology Usa, Inc.2,37315%
Sonova Ag2,15914%
Starkey Laboratories, Inc.1,50410%
Unitron Hearing Division1,2328%
Phonak Ag9716%
Unitron Hearing Ltd8375%

Top labelers

CompanyDevicesShare
Widex A/S3,09220%
Gn Hearing A/S2,67517%
Ws Audiology Usa, Inc.2,37315%
Sonova Ag2,15914%
Starkey Laboratories, Inc.1,50410%
Unitron Hearing Division1,2328%
Phonak Ag9716%
Unitron Hearing Ltd8375%
Hansaton Akustik Gmbh4143%
Hearing Lab Technology, Llc750%
Audifon Gmbh & Co. Kg560%
Novidan, Inc.400%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Phonak Audéo E50-SpherePhonak Audéo E70-SpherePhonak Audéo E90-SpherePhonak Audéo E30-RPhonak Audéo E50-RPhonak Audéo E70-RPhonak Audéo E90-RPhonak Audéo E-RPhonak Audéo E-SpherePhonak Terra+ RIC-RPhonak Terra+ RIC-312Phonak Terra RIC-312MEMINI E 2 6P R-R AI PHSonite Rise LoanerSonite Rise Kit Binaural USSonite Rise Kit Monaural US

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OSMHearing aid, air conduction with wireless technology9,861
KLWMasker, tinnitus4,391
KLWMasker, Tinnitus3,024
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescr2,537
OSMHearing Aid, Air Conduction With Wireless Technology2,242
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr2,183

GMDN & GCC registration

  • GMDN code 47169 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 33% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many air-conduction hearing aid, receiver-in-canal products are registered in the US?

15,482 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Air-conduction hearing aid, receiver-in-canal", from 25 companies. The largest labeler is Widex A/S with 20% of records.

Which FDA product codes apply?

OSM (Hearing aid, air conduction with wireless technology), KLW (Masker, tinnitus), KLW (Masker, Tinnitus), OSM (Hearing Aid, Air-Conduction With Wireless Technology, Prescr)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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