Consulting Wallah › Device Explorer › Hearing & audiology › Air-conduction hearing aid, wearable case
Device Explorer · FDA GUDID · GMDN 30082

Air-conduction hearing aid, wearable case

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn on the body (

US‑registered devices78in commercial distribution
Companies10labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Zhongshan Tianle Hearing Technology Co., Ltd.6077%
Xiamen New Sound Technology Co., Ltd.79%
Natus Medical Denmark Aps23%
Jlab23%
Elevoc Technology Co.,Ltd.23%
Jacoti11%
Beurer North America, L.P.11%
Ihear Medical, Inc.11%

Top labelers

CompanyDevicesShare
Zhongshan Tianle Hearing Technology Co., Ltd.6077%
Xiamen New Sound Technology Co., Ltd.79%
Natus Medical Denmark Aps23%
Jlab23%
Elevoc Technology Co.,Ltd.23%
Jacoti11%
Beurer North America, L.P.11%
Ihear Medical, Inc.11%
Ps Hearing Products Inc11%
Bhm-Tech Produktionsgesellschaft M.B.H.11%

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

Brand names on the register (sample)

Neosonic NW20VivtoneEarupSOUNDWEARNeosonicTIANLEGN Otometrics A/SJacoti Listen AppJLABBeureriHear EONAqusticELEHEAR AlphaELEHEAR Alpha Proapollon

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

FDA product codes

CodeNameDevices
QUGHearing Aid, Air-Conduction With Wireless Technology, Over T19
QUFHearing Aid, Air-Conduction, Over The Counter17
ESDHearing Aid, Air-Conduction, Prescription16
QSMSystem, Surgical, Computer Controlled Instrument, Remanufact15
ESDHearing Aid, Air Conduction10
OSMHearing Aid, Air Conduction With Wireless Technology2

GMDN & GCC registration

  • GMDN code 30082 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 3% · OTC 83%
  • 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 air-conduction hearing aid, wearable case products are registered in the US?

78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Air-conduction hearing aid, wearable case", from 10 companies. The largest labeler is Zhongshan Tianle Hearing Technology Co., Ltd. with 77% of records.

Which FDA product codes apply?

QUG (Hearing Aid, Air-Conduction With Wireless Technology, Over T), QUF (Hearing Aid, Air-Conduction, Over The Counter), ESD (Hearing Aid, Air-Conduction, Prescription), QSM (System, Surgical, Computer Controlled Instrument, Remanufact)

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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