Consulting Wallah › Device Explorer › Hearing & audiology › Hearing aid enhanced audio device, telecommunicati
Device Explorer · FDA GUDID · GMDN 57886

Hearing aid enhanced audio device, telecommunication/multimedia

A battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the sound q

US‑registered devices145in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription46%Rx‑only share
ShareLinkedIn

Share of device records

Starkey Laboratories, Inc.4934%
Gn Hearing A/S2517%
Widex A/S2316%
Oticon A/S107%
Sbo Hearing A/S96%
Unitron Hearing Division96%
Sonova Ag53%
Unitron Hearing Ltd53%

Top labelers

CompanyDevicesShare
Starkey Laboratories, Inc.4934%
Gn Hearing A/S2517%
Widex A/S2316%
Oticon A/S107%
Sbo Hearing A/S96%
Unitron Hearing Division96%
Sonova Ag53%
Unitron Hearing Ltd53%
Cochlear Bone Anchored Solutions Ab43%
Ws Audiology Usa, Inc.21%
Sonic Innovations, Inc.21%
Bernafon Ag21%

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

Brand names on the register (sample)

iCube IIPHONAKPhonak PilotOne IISigniaWIDEXWidexCONNEXXSonicNeutralBernafonHHMOticonPhilipsGN HearingCoselgiAMPLIFON

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 technology88
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr44
ESDHearing Aid, Air Conduction23
OSMHearing Aid, Air Conduction With Wireless Technology7
KLWMasker, tinnitus7
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescr2

GMDN & GCC registration

  • GMDN code 57886 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 46% · OTC 8%
  • 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 hearing aid enhanced audio device, telecommunication/multimedia products are registered in the US?

145 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hearing aid enhanced audio device, telecommunication/multimedia", from 12 companies. The largest labeler is Starkey Laboratories, Inc. with 34% of records.

Which FDA product codes apply?

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

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.

How do I get quotes?

Add hearing aid enhanced audio device, telecommunication/multimedia to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Hearing aid enhanced audio device, telecommunication/multimedia

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying hearing aid enhanced audio device, telecommunicati for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →