"An individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format
| Company | Devices | Share |
|---|---|---|
| Starkey Laboratories, Inc. | 1,945 | 99% |
| Desyncra Operating Gmbh | 4 | 0% |
| Desyncra Tinnitus Limited | 4 | 0% |
| Sonova Ag | 2 | 0% |
| Widex A/S | 2 | 0% |
| Aureliym Gmbh | 2 | 0% |
| Otoharmonics Corporation | 2 | 0% |
| Levo Medical Corporation | 2 | 0% |
| Sound Options Tinnitus Treatments Inc | 1 | 0% |
Company = labeler of record on GUDID. 9 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 |
|---|---|---|
| KLW | Masker, tinnitus | 1,931 |
| OSM | Hearing Aid, Air-Conduction with Wireless Technology, Prescr | 994 |
| OSM | Hearing aid, air conduction with wireless technology | 618 |
| ESD | Hearing aid, air conduction | 184 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 135 |
| KLW | Masker, Tinnitus | 33 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
1,964 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tinnitus masking application software", from 9 companies. The largest labeler is Starkey Laboratories, Inc. with 99% of records.
KLW (Masker, tinnitus), OSM (Hearing Aid, Air-Conduction with Wireless Technology, Prescr), OSM (Hearing aid, air conduction with wireless technology), ESD (Hearing aid, air conduction)
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.