Consulting Wallah › Device Explorer › Hearing & audiology › Air-conduction hearing aid, behind-the-ear
Device Explorer · FDA GUDID · GMDN 34671

Air-conduction hearing aid, behind-the-ear

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ea

US‑registered devices19,532in commercial distribution
Companies46labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Oticon A/S3,28017%
Widex A/S2,40712%
Ws Audiology Usa, Inc.2,23111%
Sbo Hearing A/S2,02110%
Sonova Ag1,7909%
Phonak Ag1,6258%
Gn Hearing A/S1,2646%
Starkey Laboratories, Inc.1,0916%

Top labelers

CompanyDevicesShare
Oticon A/S3,28017%
Widex A/S2,40712%
Ws Audiology Usa, Inc.2,23111%
Sbo Hearing A/S2,02110%
Sonova Ag1,7909%
Phonak Ag1,6258%
Gn Hearing A/S1,2646%
Starkey Laboratories, Inc.1,0916%
Unitron Hearing Ltd1,0005%
Unitron Hearing Division8424%
Bernafon Ag5103%
Hansaton Akustik Gmbh4312%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Phonak Terra+ BTE-UPPhonak Terra+ BTE-SPPhonak Terra+ BTE-MPhonak Terra BTE-UPPhonak Terra BTE-SPPhonak Terra BTE-MPhonak Naída L90-MPhonak Naída L70-MPhonak Naída L50-MPhonak Naída L30-MAu A-UPAu A-SPAu A-MAu V1-UPAu V3-UPAu V5-UP

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 technology15,552
OSMHearing Aid, Air Conduction With Wireless Technology6,786
KLWMasker, tinnitus4,793
ESDHearing Aid, Air Conduction2,183
KLWMasker, Tinnitus2,012
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr1,821

GMDN & GCC registration

  • GMDN code 34671 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 54% · 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

Length (Millimeter) · 7Width (Millimeter) · 7Height (Millimeter) · 5

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

How many air-conduction hearing aid, behind-the-ear products are registered in the US?

19,532 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Air-conduction hearing aid, behind-the-ear", from 46 companies. The largest labeler is Oticon A/S with 17% of records.

Which FDA product codes apply?

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