The First Fully Implanted Cochlear Implant Reaches Patients

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Med-El has launched the TICI Unico, which places a cochlear implant’s microphone, processor and battery beneath the skin. Four commercial implantations took place on the announcement day after European regulatory approval; the device is not yet available in the United States. Early studies reported hearing performance comparable to conventional implants, but broader long-term results remain to be established.

Austrian company Med-El has launched the TICI Unico, a cochlear implant with its microphone, sound processor and rechargeable battery beneath the skin, and says four patients received commercial implants on the morning of the announcement. The device has European regulatory approval, but is not yet available in the United States; it aims to let users hear without wearing or managing an external processor.

Conventional cochlear implants use an external unit worn behind the ear. It contains a microphone, sound processor and battery, and sends signals through the scalp to an electrode array in the cochlea, the spiral-shaped inner-ear structure. The TICI Unico puts the components under the skin. Med-El says users can hear while sleeping or swimming, activities that can be limited by external processors.

The implant weighs 20 grams and has four connected components, including a small microphone placed under the scalp and a stimulator that houses processing hardware and a rechargeable lithium-ion battery. A magnetic, car-key-size device called a GoPod charges it through the skin. Med-El says a charge takes about one to 1.5 hours and can provide up to 40 hours of use. The battery cannot be replaced; the company says its performance data indicates it should support at least 24 hours of use per charge for at least 15 years.

Med-El says a 30-patient clinical trial found hearing performance “comparable” to its conventional implants. Philippe Lefebvre, an ear, nose and throat department head at University Hospital of Liège who led a six-patient feasibility study published in Communications Medicine last year, also said the early results suggest comparable performance. These findings come from limited studies and do not establish how the device will perform across a broader population or over longer periods.

Hearing Without an External Processor

The launch addresses a practical limitation of conventional cochlear implants: their external processor must be worn and managed, and can be affected by activities such as swimming. A fully implanted system could allow users to receive sound continuously without removing the processor for sleep or water activities, though individual results and daily routines will vary.

The change also shifts key hardware beneath the skin, including the microphone. Med-El’s senior research and development engineer and project leader, Gerhard Mark, said sound behaves differently as it travels through tissue and that reaching the required performance took years of research and refinement. The company has not disclosed the technical details of how it handled that challenge.

For people considering an implant, the reported benefits come with trade-offs that warrant attention: the battery is rechargeable but cannot be replaced, and long-term performance claims are based on company data. The device’s launch gives clinicians and prospective users a new option to evaluate, while wider availability and evidence from more patients will shape how significant the change proves to be.

From Early Ambition to Launch

Cochlear implants have been used since the 1980s to bypass damaged parts of the ear in people with severe-to-profound hearing loss. Most systems rely on an external unit that captures and processes sound before sending signals to an electrode array in the cochlea.

Med-El chief executive Ingeborg Hochmair said the ambition to make a fully implanted cochlear implant dates to the 1970s, when she and her husband, Erwin, worked on early multichannel implants. She said microphone and battery technology held back the idea. The company says development of the TICI Unico took more than 15 years.

Before the commercial launch, the device was tested in clinical studies. One volunteer, Diana Grosser, received an implant in 2024 as part of a clinical trial. The six-patient feasibility study led by Lefebvre was published last year; the source report also says other studies cited by Hochmair had not yet been peer reviewed.

““For the first time, all components of a cochlear implant, including the microphone, are implanted beneath the skin.””

— Ingeborg Hochmair, Med-El chief executive

Evidence and Access Still Limited

The report does not specify the calendar date of the announcement or identify the first four commercial recipients. It also does not state when, or whether, Med-El plans to seek availability in the United States.

The reported trial involved 30 patients, and the published feasibility study involved six. The source does not provide detailed results, participant characteristics or follow-up periods for the 30-patient trial. Some additional study results mentioned by Hochmair were still awaiting peer review, according to the report. Broader evidence is needed to assess performance and reliability over time and across different users.

The company says battery performance data points to at least 24 hours of use per charge for at least 15 years, but the report does not describe the data or independently verify that projection. The battery cannot be replaced, and the report does not detail what maintenance or replacement would involve if it no longer meets users’ needs.

More Patients and Market Access

The immediate next step is for the device to reach more eligible patients in markets where it is approved. The source does not give a rollout schedule, price or details about which clinics will offer it. Its availability in the United States remains pending, with no timeline reported.

Further clinical follow-up and peer-reviewed results will help clarify how the implanted microphone performs in everyday listening and how the system holds up over time. Prospective users and clinicians will also need information about charging routines, device care and the implications of a non-replaceable battery. Zeng said he hopes Med-El’s launch will prompt other companies to bring similar products forward, but the report does not identify any competing launch plans.

Key Questions

What is the TICI Unico?

It is Med-El’s fully implanted cochlear implant. The company says its microphone, sound processor and rechargeable battery sit beneath the skin, with an electrode array placed in the cochlea.

Has the device reached patients?

Yes. Med-El said four commercial implantations took place on the morning of the announcement. A clinical-trial volunteer had received the device in 2024.

Where is the TICI Unico available?

It has European regulatory approval. The source report says it is not yet available in the United States and gives no U.S. launch date.

How long does the battery last?

Med-El says a charge of about one to 1.5 hours can provide up to 40 hours of use. The company says its performance data indicates a minimum of 24 hours per charge for at least 15 years. The battery is rechargeable and cannot be replaced.

Does it work as well as a conventional cochlear implant?

Med-El says a 30-patient clinical trial found comparable hearing performance. A separate six-patient feasibility study leader also described the early results as comparable. The available findings are limited, and longer-term performance remains unclear.

Source: hn