Consulting Wallah › Device Explorer › Catheters & tubes › Air-conduction hearing aid acoustic tube
Device Explorer · FDA GUDID · GMDN 62260

Air-conduction hearing aid acoustic tube

A small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device

US‑registered devices502in commercial distribution
Companies6labelers on GUDID
Single‑use51%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Tomore Medical (Shenzhen) Co., Ltd25651%
Tomore Healthcare (Dongguan) Co.,Ltd.10922%
Gn Hearing A/S8216%
Dreve Otoplastik Gmbh4810%
Soundwave Hearing, Llc61%
Hearing Lab Technology, Llc10%

Top labelers

CompanyDevicesShare
Tomore Medical (Shenzhen) Co., Ltd25651%
Tomore Healthcare (Dongguan) Co.,Ltd.10922%
Gn Hearing A/S8216%
Dreve Otoplastik Gmbh4810%
Soundwave Hearing, Llc61%
Hearing Lab Technology, Llc10%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TOMOREGN HearingTubingTube end pieceArc tubing connectionPre-bent tubingSmall nylon tubingAnchor part connectionSilicone tubingSilicone TubingSoundwave HearingLucid®

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

FDA product codes

CodeNameDevices
QUFHearing Aid, Air-Conduction, Over The Counter135
QUGHearing Aid, Air-Conduction With Wireless Technology, Over T106
OSMHearing aid, air conduction with wireless technology88
ESDHearing Aid, Air-Conduction, Prescription85
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescr62
ESDHearing aid, air conduction28

GMDN & GCC registration

  • GMDN code 62260 · non‑implantable
  • Single‑use 51% · sterile 0% · Rx‑only 0% · OTC 1%
  • 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 air-conduction hearing aid acoustic tube products are registered in the US?

502 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Air-conduction hearing aid acoustic tube", from 6 companies. The largest labeler is Tomore Medical (Shenzhen) Co., Ltd with 51% of records.

Which FDA product codes apply?

QUF (Hearing Aid, Air-Conduction, Over The Counter), QUG (Hearing Aid, Air-Conduction With Wireless Technology, Over T), OSM (Hearing aid, air conduction with wireless technology), ESD (Hearing Aid, Air-Conduction, Prescription)

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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