Consulting Wallah › Device Explorer › Hearing & audiology › Hearing aid wireless-fitting computer-aided set
Device Explorer · FDA GUDID · GMDN 57884

Hearing aid wireless-fitting computer-aided set

A collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer

US‑registered devices746in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription67%Rx‑only share
ShareLinkedIn

Share of device records

Sbo Hearing A/S48765%
Bernafon Ag10314%
Oticon A/S8511%
Sonic Innovations, Inc.527%
Cochlear Bone Anchored Solutions Ab71%
Widex A/S51%
Persona Medical20%
Starkey Laboratories, Inc.20%

Top labelers

CompanyDevicesShare
Sbo Hearing A/S48765%
Bernafon Ag10314%
Oticon A/S8511%
Sonic Innovations, Inc.527%
Cochlear Bone Anchored Solutions Ab71%
Widex A/S51%
Persona Medical20%
Starkey Laboratories, Inc.20%
Cochlear Americas Corporation20%
Sonova Ag10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Phonak BrandOticonBernafonPhilipsBirdsongHHMMaicoNeutralSonitonSonicAGXOEarQAudilabViOWidexPersona Medical

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

FDA product codes

CodeNameDevices
KLWMasker, tinnitus708
OSMHearing aid, air conduction with wireless technology415
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr316
LXBHearing aid, bone conduction10
OSMHearing Aid, Air Conduction With Wireless Technology7
ESDHearing Aid, Air Conduction3

GMDN & GCC registration

  • GMDN code 57884 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 67% · OTC 0%
  • 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 wireless-fitting computer-aided set products are registered in the US?

746 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hearing aid wireless-fitting computer-aided set", from 10 companies. The largest labeler is Sbo Hearing A/S with 65% of records.

Which FDA product codes apply?

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

How do I get quotes?

Add hearing aid wireless-fitting computer-aided set 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 wireless-fitting computer-aided set

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 wireless-fitting computer-aided set 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 →