Consulting Wallah › Device Explorer › Hearing & audiology › Contralateral hearing unit
Device Explorer · FDA GUDID · GMDN 59460

Contralateral hearing unit

A passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routin

US‑registered devices332in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Ws Audiology Usa, Inc.23571%
Sonova Ag9027%
Widex A/S41%
Gn Hearing A/S31%

Top labelers

CompanyDevicesShare
Ws Audiology Usa, Inc.23571%
Sonova Ag9027%
Widex A/S41%
Gn Hearing A/S31%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Phonak CROS E-RPhonak CROS I-RPhonak BrandPhonak CROS I-R TrialSonova BrandPHONAKPhonakSigniaMiracle-EarREXTONSIGNIAAmplifonRextonGN HearingWidex

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

FDA product codes

CodeNameDevices
KLWMasker, Tinnitus183
OSMHearing Aid, Air Conduction With Wireless Technology148
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescr124
OSMHearing aid, air conduction with wireless technology46
ESDHearing Aid, Air Conduction17

GMDN & GCC registration

  • GMDN code 59460 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 71% · 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 contralateral hearing unit products are registered in the US?

332 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Contralateral hearing unit", from 4 companies. The largest labeler is Ws Audiology Usa, Inc. with 71% 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), 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?

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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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