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 built into the arm
| Company | Devices | Share |
|---|---|---|
| Luxottica Group Spa | 47 | 92% |
| Legato Audio, Inc. | 4 | 8% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| SCR | Air-Conduction Hearing Aid Software | 49 |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over T | 4 |
Use these as the dimensions to specify in a tender line.
51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Air-conduction hearing aid, spectacle", from 2 companies. The largest labeler is Luxottica Group Spa with 92% of records.
SCR (Air-Conduction Hearing Aid Software), QUG (Hearing Aid, Air-Conduction With Wireless Technology, Over T)
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.