TL;DR
Turn quiet afternoons into listening time
- Thousands of audiobooks, podcasts and originals
- Listen on your phone, tablet or Echo — also offline
- Cancel anytime
Med-El has launched the TICI Unico, a cochlear implant with all components beneath the skin, and says European regulators have approved it. Four commercial implantations were performed on launch day; clinical evidence and long-term performance remain limited, and the device is not yet available in the United States.
Austrian hearing-technology company Med-El has launched the TICI Unico, a cochlear implant with its microphone, processor and battery implanted beneath the skin, and says it has received European regulatory approval. The company said the first four commercial implantations took place on the morning of the announcement, marking the first commercial release of a fully implanted cochlear implant; the device is not yet available in the United States.
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. TICI Unico places the microphone and other electronics under the skin, so users do not need to wear or remove an external sound processor. The system weighs 20 grams and connects to the same type of cochlear electrode array used in Med-El’s conventional implants.
Med-El says its clinical trial of 30 patients found hearing performance comparable to its conventional implants. The source report does not provide detailed trial results. The device’s battery is rechargeable but cannot be replaced; the company says a full charge takes about one to 1.5 hours and is designed to provide up to 40 hours of use. It says performance data suggest the battery will support at least 24 hours of use per charge for at least 15 years.
Charging uses a small unit called the GoPod, which attaches magnetically through the skin to a coil in the implant. Med-El says the fully implanted design can let users hear while sleeping, swimming or recharging their device. Those capabilities and reported performance are claims from the company and trial participants; they do not establish how the device will work for every recipient.
Hearing Without an External Processor
The launch addresses a practical limitation of conventional cochlear implants: users generally have to wear an external processor to hear through the device. With its components beneath the skin, TICI Unico could give recipients more freedom during activities when an external unit may be inconvenient, including swimming or sleeping. The design also removes the visible processor, which some users may value.
In a six-patient feasibility study, University Hospital of Liège ENT department head Philippe Lefebvre said participants identified round-the-clock hearing as the main benefit, ahead of the device’s invisibility. One volunteer, Diana Grosser, said the implant let her swim and ride a motorcycle without worrying about an external processor slipping or getting lost. These are individual accounts, not measures of how all recipients will experience the device.
The product may also put pressure on other implant makers to develop similar systems. Fan-Gang Zeng, a University of California, Irvine hearing researcher who is not affiliated with Med-El, welcomed the launch and said it could encourage competition. Whether other companies follow, and how the new design compares in broader use, remains to be seen.
Popular right now
Ninja CREAMi 7-in-1 Ice Cream Maker, NC299AMZ
De'Longhi Rivelia Automatic Espresso Machine with Milk Frother
Samsung 85-Inch QN70H Neo QLED 4K Smart TV (2026)
As an affiliate, we earn on qualifying purchases.
From Early Ambition to Approval
Cochlear implants have been used since the 1980s to help people with severe-to-profound hearing loss. They bypass damaged parts of the ear by converting sound into electrical signals that stimulate the auditory nerve through an electrode array in the cochlea. Conventional systems have relied on an external microphone and processor.
Med-El CEO Ingeborg Hochmair said the goal of a fully implanted implant dates to the 1970s, but earlier microphone and battery technology posed obstacles. The company says development of TICI Unico took more than 15 years. The most difficult task, according to project leader and senior R&D engineer Gerhard Mark, was getting a microphone beneath the scalp to capture sound effectively because sound travels differently through tissue.
A six-patient feasibility study led by Lefebvre was published in Communications Medicine last year, according to the source report. Hochmair said other studies also found comparable performance, but that data had not yet undergone peer review at the time of the report.
“For the first time, all components of a cochlear implant, including the microphone, are implanted beneath the skin. There are no external components to wear, to remove, or to manage.”
— Ingeborg Hochmair, Med-El chief executive
Trial Evidence and Battery Life
The available evidence described in the report is limited: a 30-patient company trial and a published feasibility study involving six patients. The full results of the company trial, including participant characteristics, measured outcomes and follow-up duration, are not provided. The report also says data from other studies were awaiting peer review, so their methods and findings cannot yet be independently evaluated from the information available.
Med-El’s battery estimates are based on performance data and are not a guarantee of actual use for each recipient. The battery cannot be replaced, and the report does not explain what happens if its capacity falls short of the stated expectations. It also does not give details about potential risks, eligibility criteria, cost, or how patients will fare over longer periods.
European approval is confirmed by the company’s account in the report, but the specific approval date and details of the regulatory authorization are not given. U.S. availability is still pending; the report does not state when an application or decision might follow.
Availability and Longer Follow-Up
The first four commercial implantations have taken place, according to Med-El. The next developments to watch are wider patient access in Europe, publication and review of additional clinical results, and reports on hearing performance and battery life over longer periods. The source report gives no schedule for any of these milestones.
U.S. availability will depend on further regulatory steps, but Med-El’s plans and timing for the country are not specified. As more recipients use the device, evidence will be needed to clarify how consistently its performance compares with conventional implants and how the implanted microphone and nonreplaceable battery hold up in everyday use.
Key Questions
What is the TICI Unico?
It is Med-El’s fully implanted cochlear implant. The microphone, sound processor and rechargeable battery sit beneath the skin and connect to an electrode array in the cochlea.
Has the device reached patients?
Yes. Med-El said European regulators approved the device and that four commercial implantations took place on the morning it was launched. The report does not identify the recipients or their outcomes.
How long does the battery last?
Med-El says the battery is designed to provide up to 40 hours on a charge. The company says performance data suggest at least 24 hours per charge for at least 15 years. These are company estimates, and the battery cannot be replaced.
Is TICI Unico available in the United States?
No. The source report says the device is not yet available in the United States and gives no timeline for U.S. availability.
Does it work as well as a conventional cochlear implant?
Med-El says its 30-patient trial found comparable hearing performance. The report does not provide detailed results, and broader, longer-term evidence is still needed to assess performance across patients.
Source: hn
