The short version
- MED-EL’s TICI UNICO is a cochlear implant with every part under the skin, including the microphone and a rechargeable battery.
- It has European approval for adults with severe-to-profound hearing loss and is not approved in the United States.
- The company’s 30-patient trial reported hearing comparable to its standard implants, but those results are not yet published.
The Austrian company MED-EL put the TICI UNICO on sale in Europe on September 29. Every part of it sits under the skin. A conventional cochlear implant needs an external processor and microphone worn on the head. Here a microphone about the width of a US nickel sits roughly 6 mm under the scalp, behind the ear, wired to a stimulator with a rechargeable battery. The implant weighs 20 grams. A charge lasts up to 40 hours and takes about an hour to an hour and a half through a magnetic pad, and sound keeps working while it charges. That means hearing while asleep or swimming. By launch day, 40 people had one.
The evidence is thinner than the engineering. MED-EL says a 30-patient trial found hearing “comparable” to its standard implants. Those results have been submitted to a journal but are not yet published. A six-patient feasibility study from Liège came out last year. The battery cannot be swapped without more surgery, skin thickness affects what the microphone picks up, and there is no direct Bluetooth streaming. How the battery and microphone hold up over years is not yet known.
The approval covers adults with severe-to-profound sensorineural hearing loss. The device is not approved in the United States, and MED-EL gave no timeline for the FDA. Cochlear took a different route this month, with an implant whose firmware can be upgraded after surgery.
