An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic
| Company | Devices | Share |
|---|---|---|
| Prentke Romich Company | 280 | 77% |
| Lingraphicare America, Inc. | 20 | 6% |
| Tobii Dynavox Llc | 16 | 4% |
| Talk To Me Technologies, Llc | 16 | 4% |
| Smartbox Assistive Technology Inc. | 12 | 3% |
| Forbes Rehab Services Inc | 8 | 2% |
| Rm Speech | 7 | 2% |
| Control Bionics Incorporated | 2 | 1% |
| Abilia Ab | 1 | 0% |
| Irisbond Crowdbonding Sl. | 1 | 0% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| ILQ | System, Communication, Powered | 404 |
| IQA | System, Environmental Control, Powered | 2 |
| LNX | Medical Computers And Software | 1 |
Use these as the dimensions to specify in a tender line.
363 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Voice synthesizer/digitizer", from 10 companies. The largest labeler is Prentke Romich Company with 77% of records.
ILQ (System, Communication, Powered), IQA (System, Environmental Control, Powered), LNX (Medical Computers And Software)
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.