AI software for speech and language after stroke
Aphonos builds conversational software for people who lost their language to a stroke. Aphasia.ai, a conversation practice app, is available today. Separately, our research program is working toward a prescription digital therapeutic for post-stroke aphasia.
áphonos · Greek · voiceless
The problem
Aphasia is the loss of language following a stroke or brain injury. It affects more people than Parkinson's disease, cerebral palsy, or muscular dystrophy. Most people have never heard of it.
Existing tools either digitize traditional drills or help patients compensate for lost language. None of them is built around who the person actually is, and none has been taken through the FDA for aphasia.
That is the gap Aphonos is building into.
Our approach
Aphonos combines conversational AI, pre-stroke identity personalization, and a caregiver layer into a single platform, built from the ground up for people living with aphasia.
Every session is shaped by who the person was before their stroke: their career, family, hobbies, and life. This is not a feature. It is the architecture.
The conversation follows the person’s pace and energy that day, and stays on things they care about.
After every session, families can see what was talked about and get a topic idea for next time. Practice is a team effort. We built the platform that way from day one.
Pipeline
These programs are investigational and separate from Aphasia.ai, our consumer app. The dashed line marks regulatory submission. Nothing to the right of it is authorized yet.
| Program | Indication and intended use | Route |
Research &
discovery Development &
feasibility Clinical validation
pivotal RCT Regulatory
submission Authorised /
listed Reimbursed &
available |
|---|---|---|---|
| APH‑201 Unnamed | Post-stroke aphasia, naming and connected speech. Intended for use alongside care from a speech-language pathologist. | US · De Novo Anticipated. No predicate device exists |
NIDCD SBIR Phase I |
| APH‑301 Unnamed | Post-stroke aphasia. German statutory reimbursement market. | DE · DiGA, CE IIa Planned |
|
Regulatory pathway and device classification are subject to FDA feedback, and any study qualifying as pivotal is subject to FDA feedback and review of data. Programs in research and development are not FDA-cleared, not FDA-authorized, and are not available for prescription. Aphasia.ai is not part of these programs.
The consumer product
A conversational companion for stroke survivors and their families, available directly with no clinical referral. It is where people practice everyday conversation at home.
It is a separate product from our clinical research programs, with its own name, release and pricing.
Visit Aphasia.ai →Evidence and collaborators
An early company's credibility is the checkable part. Named collaborators, named methods, and a regulatory position we can defend, rather than user counts.
A feasibility study is planned with an academic aphasia center as the study site, with a named speech-language pathologist as collaborator. We will name the site and the investigator here once the collaboration is announced.
Application submitted to the National Institute on Deafness and Other Communication Disorders, September 2026.
The clinical research program (APH‑201) builds on established methods from aphasia research:
There is no FDA-cleared predicate device for aphasia. The existing digital therapeutic classifications are indication-locked, including 21 CFR 882.5801, which is limited on its face to psychiatric conditions.
The anticipated route for APH‑201 is therefore a De Novo classification request, which would open the category and set the special controls every subsequent product has to meet.
Streaming speech recognition tuned for disordered speech and a two-layer language model architecture.
Speech recognition is never the only input. Every activity has a parallel path that does not depend on the system understanding what was said.
Get in touch
Whether you're an investor, a speech-language pathologist, a clinical researcher, or exploring a partnership, we'd like to hear from you.