Consulting Wallah › Device Explorer › Hearing & audiology › Air-conduction hearing aid, receiver-in-the-ear
Device Explorer · FDA GUDID · GMDN 56736

Air-conduction hearing aid, receiver-in-the-ear

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 or microphones and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to

US‑registered devices6,698in commercial distribution
Companies13labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Oticon A/S3,11446%
Sbo Hearing A/S2,27034%
Bernafon Ag6109%
Hearing Lab Technology, Llc3866%
Sonic Innovations, Inc.2804%
Yeasound (Xiamen) Hearing Technology Co., Ltd170%
Hearing Assist Ii, Inc.60%
Hetaida Technology Co., Ltd30%

Top labelers

CompanyDevicesShare
Oticon A/S3,11446%
Sbo Hearing A/S2,27034%
Bernafon Ag6109%
Hearing Lab Technology, Llc3866%
Sonic Innovations, Inc.2804%
Yeasound (Xiamen) Hearing Technology Co., Ltd170%
Hearing Assist Ii, Inc.60%
Hetaida Technology Co., Ltd30%
Widex A/S30%
Vive Health Llc30%
Huizhou Jinghao Medical Technology Co., Ltd20%
Austar Hearing Science & Technology (Xiamen) Co., Ltd Men) Co., Ltd.20%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NANANOHetaidaJoyhicareAUSTAROticonGPLHHMBernafonPhilipsBirdsongAGXOEarQSonicCostcoAccuQuest

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 technology5,464
KLWMasker, tinnitus1,718
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr1,086
ESDHearing aid, air conduction107
QUGHearing Aid, Air-Conduction with Wireless Technology, Over t36
QUGHearing Aid, Air-Conduction With Wireless Technology, Over T25

GMDN & GCC registration

  • GMDN code 56736 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 98% · OTC 1%
  • 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-the-ear products are registered in the US?

6,698 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-the-ear", from 13 companies. The largest labeler is Oticon A/S with 46% of records.

Which FDA product codes apply?

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

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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