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Accreditations
Hearing care you can trust.
eargym is a registered medical device in the UK and the US, a Certified B Corporation, and works with Cleveland Clinic and Mayo Clinic. Every credential below can be checked at source.
UK Class I medical device: Registered with the MHRA
FDA-registered Class II: Reg. no. 3043496923
Certified B Corporation: B Impact score 100.8 (50.9 is the median score for ordinary businesses, and 80 qualifies for B Corp certification)
A registered medical device
eargym’s hearing checks and training are built and documented to medical device standards in the UK and the US.
UK Class I medical device
Since August 2024, eargym has been a Class I medical device under the UK Medical Devices Regulations 2002, registered with the Medicines and Healthcare products Regulatory Agency (MHRA). We declare that eargym meets the UK’s safety and performance requirements for medical devices and keep the technical file to prove it.
Why it matters to you:
Your hearing check and training aren’t just a wellness game. They’re built, tested and documented to the standards UK law sets for medical devices.
Registration reference 2024082201382350.
FDA-registered Class II medical device
FDA Class II, Registration no. 3043496923
In February 2026, eargym was registered with the US Food and Drug Administration as a Class II medical device, in a category the FDA lets companies market without a premarket submission (510(k) exempt), as long as they meet its general requirements for medical devices. Our FDA registration number is 3043496923.
Why it matters to you:
eargym can be offered to people in the US by insurers, employers and clinics, with the same medical-grade hearing check and training used in the UK.
Search the FDA device register.
Certified B Corporation
B Lab certified eargym as a B Corp in November 2023, after an independent assessment of our social, environmental and governance impact. We scored 100.8, where 80 is needed to qualify and the median for ordinary businesses is 50.9.
Why it matters to you:
We’re legally committed to balancing profit with purpose, and we’re reassessed every three years to keep the certification.
See our B Corp profile.
Built with world-leading clinics
We work with hospital audiology and neurology teams to design new hearing care and to test what works.
Cleveland Clinic
Audiologists at Cleveland Clinic and the eargym team co-developed a training app for people learning to hear again after a cochlear implant, funded by Cleveland Clinic and announced in February 2026. It’s now available as the eargym CI Rehab app.
Why it matters to you:
The same game-based approach behind the core eargym app was shaped by specialists who work with implant patients every day to specifically support new CI recipients.
Read about the collaboration.
Mayo Clinic Berg Innovation Exchange
In July 2026, eargym was accepted into the Mayo Clinic Berg Innovation Exchange (MCBIE) Waypoints Program. Over 12 weeks, we were offered the opportunity to work with Mayo Clinic specialists in audiology, ENT, cognitive neurology and behavioural science to design our first pivotal randomised controlled trial.
Why it matters to you:
In 2027, we’ll be putting our digital hearing training through the most rigorous kind of clinical test, including its effect on memory and thinking.
Read the announcement.
Partners and programmes
Health plans that offer eargym to their members, and programmes that picked us to grow.
Medicash
Since March 2025, more than 600k people covered by Medicash health plans can use eargym’s hearing checks and training through the My Medicash App.
Why it matters to you:
If your employer offers Medicash, you may already have eargym included in your plan.
Check eargym on Medicash.
AgeTech Collaborative™ from AARP
eargym was selected for AARP’s competitive eight-week accelerator, joining the spring 2026 cohort on April 2026. AARP’s researchers, consumer insight team and experts helped us shape eargym for older adults in the US.
Why it matters to you:
eargym has been tested and refined with input from the largest organisation for people over 45 in the US.
Read AARP’s profile of eargym.
Insurtech UK
eargym is a member of Insurtech UK, the trade association for the UK’s insurance technology sector, which connects members with insurers, investors and regulators. [Add “since month year” once confirmed, for SEO/GE.]
Why it matters to you:
We work with insurers to make preventative hearing care part of the cover people already have.
Breakthrough Founders
eargym is part of Breakthrough Founders, a UK-wide, 12-month pathway to investment for founders from underrepresented groups, funded by Innovate UK and run by The200BnClub, Catalyst, Focused For Business and Mint Ventures.
Why it matters to you:
The programme gave us expert feedback on our business plans, pitch materials and commercial model.
Where you’ve seen eargym
Alzheimer’s Society Annual Conference
17 September 2026
Joined researchers and health leaders sharing progress on early detection and risk reduction for dementia.
HLTH 2025
19–22 October 2025
Made the case that unaddressed hearing loss is a financial and cognitive risk health systems can act on early.
Award-winning from the start
2023: Longitude Prize on Dementia, semifinalist
2023: Apple, featured in Fitness & Well-being Apps by Women
2022: UKRI Designed for Ageing, winner
2022: Alzheimer’s Society Innovation Accelerator and grant funding
What this means for you:
✅ Medical-grade, not just a game. eargym is a registered medical device in the UK and the US.
✅ Shaped by clinicians. Built with Cleveland Clinic audiologists and tested with Mayo Clinic specialists.
✅ Maybe already covered. Available through Medicash health plans at no extra cost.
✅ Designed for later life. Refined with AARP’s experts on ageing.
✅ Run responsibly. A Certified B Corp, independently reassessed every three years.
✅ Checkable at source. Every credential on this page links to the organisation that granted it.
FAQ
Is eargym a medical device?
Yes. eargym is a UK Class I medical device registered with the MHRA since August 2024, and an FDA-registered Class II medical device (510(k) exempt) since February 2026.
Is eargym FDA approved?
No. eargym is FDA-registered and listed, not approved or cleared. It’s in a Class II category the FDA allows to be marketed without a premarket submission, provided it meets the FDA’s general requirements.
What is eargym’s FDA registration number?
3043496923.
Is eargym a B Corp?
Yes. eargym Ltd has been a Certified B Corporation since November 2023, with a B Impact score of 100.8.
Which clinics has eargym worked with?
eargym has worked with Cleveland Clinic, on a cochlear implant rehabilitation programme. eargym was also selected for the Berg Innovation Exchange Waypoints Program, from Mayo Clinic, to design eargym’s first randomised controlled trial.
Can I get eargym through my health plan?
In the UK, eargym is included for people on company-funded Medicash health plans, through the My Medicash App.
eargym Ltd
167–169 Great Portland Street, 5th Floor, London, W1W 5PF.
FDA Registration Number 3043496923.
Email: support@eargym.world
Last updated 11 November 2026.