Consulting Wallah › Device Explorer › Hearing & audiology › Bone-conduction hearing aid, head-worn
Device Explorer · FDA GUDID · GMDN 65091

Bone-conduction hearing aid, head-worn

An electrically-powered, external, acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically incorporates a microphone, amplifier, and vibrator mounted

US‑registered devices57in commercial distribution
Companies5labelers on GUDID
Single‑use23%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Bhm-Tech Produktionsgesellschaft M.B.H.2951%
Medtronic Xomed, Inc.1221%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.1221%
Shenzhen Magnet Technology Co., Ltd35%
Primed Medical Products Inc12%

Top labelers

CompanyDevicesShare
Bhm-Tech Produktionsgesellschaft M.B.H.2951%
Medtronic Xomed, Inc.1221%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.1221%
Shenzhen Magnet Technology Co., Ltd35%
Primed Medical Products Inc12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

UltrotingPRIMEDOtomag™ Alpha 2 Sound Processorcontact fortecontact forte Alphacontact minicontact star evo1AN-Evo1ADHEAR Audio Processor (701), Test Device, lockADHEAR Audio Processor (701), Terra Brown, lockADHEAR Audio Processor (701), Dove Silver, lockADHEAR Audio Processor (701), Simply Black, lockADHEAR Professional KitADHEAR User Kit, Terra BrownADHEAR User Kit, Dove SilverADHEAR User Kit, Simply Black

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

FDA product codes

CodeNameDevices
LXBHearing Aid, Bone Conduction85
LXBHearing aid, bone conduction37
LBXPELVIMETER, INTERNAL4
FYAGown, Surgical1

GMDN & GCC registration

  • GMDN code 65091 · non‑implantable
  • Single‑use 23% · sterile 0% · Rx‑only 98% · 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 bone-conduction hearing aid, head-worn products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone-conduction hearing aid, head-worn", from 5 companies. The largest labeler is Bhm-Tech Produktionsgesellschaft M.B.H. with 51% of records.

Which FDA product codes apply?

LXB (Hearing Aid, Bone Conduction), LXB (Hearing aid, bone conduction), LBX (PELVIMETER, INTERNAL), FYA (Gown, Surgical)

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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