A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home
| Company | Devices | Share |
|---|---|---|
| Sonova Ag | 258 | 34% |
| Gn Hearing A/S | 138 | 18% |
| Sbo Hearing A/S | 93 | 12% |
| Widex A/S | 57 | 8% |
| Cochlear Limited | 52 | 7% |
| Oticon A/S | 39 | 5% |
| Med-El Elektromedizinische Geräte Gesellschaft M.B.H. | 23 | 3% |
| Bernafon Ag | 21 | 3% |
| Starkey Laboratories, Inc. | 12 | 2% |
| Oticon Medical Ab | 11 | 1% |
| Unitron Hearing Division | 9 | 1% |
| Ws Audiology Usa, Inc. | 8 | 1% |
Company = labeler of record on GUDID. 22 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 |
|---|---|---|
| OSM | Hearing aid, air conduction with wireless technology | 604 |
| OSM | Hearing Aid, Air-Conduction with Wireless Technology, Prescr | 229 |
| KLW | Masker, tinnitus | 165 |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescr | 119 |
| MCM | IMPLANT, COCHLEAR | 33 |
| OSM | Hearing Aid, Air Conduction With Wireless Technology | 30 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
754 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Audiometric/hearing device software", from 22 companies. The largest labeler is Sonova Ag with 34% of records.
OSM (Hearing aid, air conduction with wireless technology), OSM (Hearing Aid, Air-Conduction with Wireless Technology, Prescr), KLW (Masker, tinnitus), OSM (Hearing Aid, Air-Conduction With Wireless Technology, Prescr)
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.