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Device Explorer · FDA GUDID · GMDN 57885

Hearing aid/implant system remote control

A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., car

US‑registered devices354in commercial distribution
Companies16labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription45%Rx‑only share
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Share of device records

Sbo Hearing A/S15744%
Oticon A/S5516%
Gn Hearing A/S288%
Widex A/S267%
Bernafon Ag195%
Sonic Innovations, Inc.154%
Starkey Laboratories, Inc.134%
Cochlear Limited82%

Top labelers

CompanyDevicesShare
Sbo Hearing A/S15744%
Oticon A/S5516%
Gn Hearing A/S288%
Widex A/S267%
Bernafon Ag195%
Sonic Innovations, Inc.154%
Starkey Laboratories, Inc.134%
Cochlear Limited82%
Ws Audiology Usa, Inc.72%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.62%
Amplifon Spa51%
Sonova Ag41%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Phonak MiniControlIIC Remote ControlPhonak BrandPhonakUNITRONSIGNIANAWIDEXhear.comRextonAudioServicemyRemoteSigniaTruHearingOticonPhilips

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 technology253
KLWMasker, tinnitus179
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr77
OSMHearing Aid, Air Conduction With Wireless Technology16
ESDHearing Aid, Air Conduction15
MCMIMPLANT, COCHLEAR10

GMDN & GCC registration

  • GMDN code 57885 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 45% · OTC 5%
  • 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.

No closely related category with 50+ devices.

How many hearing aid/implant system remote control products are registered in the US?

354 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hearing aid/implant system remote control", from 16 companies. The largest labeler is Sbo Hearing A/S with 44% 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), 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.

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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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