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Med-El launched the TICI Unico, which places all cochlear implant components beneath the skin, and says four patients received it on launch day. The company reports comparable hearing performance to its conventional implants, but the device is not yet available in the United States.
Austrian medical-device company Med-El has launched the TICI Unico, which places a cochlear implant’s microphone, sound processor and battery beneath the skin, and says the first four commercial implantations took place on the morning of the announcement. The device has European regulatory approval and is not yet available in the United States, marking a new option for some people with severe-to-profound hearing loss who want to use an implant without 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 TICI Unico moves the microphone and processing hardware under the skin while retaining an electrode array like those used in Med-El’s conventional implants. The four components together weigh 20 grams, according to the company.
A small microphone sits about 6 millimeters beneath the scalp. A postage-stamp-size stimulator contains the sound-processing hardware and a rechargeable lithium-ion battery. Users recharge it through the skin with a magnetic, car-key-size device called a GoPod. Med-El says a charge takes about one to one and a half hours and can provide up to 40 hours of use. The company says performance data indicates the battery should sustain at least 24 hours of use per charge for at least 15 years; the battery cannot be replaced.
Med-El says a 30-patient clinical trial found hearing performance “comparable” to its conventional implants. That is the company’s description of the results; the supplied report does not provide detailed outcome measures for the trial. A separate six-patient feasibility study led by Philippe Lefebvre was published in Communications Medicine last year. Other results cited by the company are still awaiting peer review.
Hearing Without an External Processor
The change may affect everyday activities that can be difficult with an external processor. Med-El says the fully implanted system lets users hear while asleep, swimming and recharging the device, when conventional external components may need to be removed or managed. The implant also avoids a visible processor behind the ear, a feature that may matter to some users.
However, the early reports suggest that continuous access to hearing may be as important as appearance. Lefebvre, who led the feasibility study, said users identified the ability to hear around the clock as the main benefit. Diana Grosser, who received the device in 2024 during the clinical trial, described greater freedom in activities with her children, swimming and riding a motorcycle. Her experience is an individual account, not evidence of outcomes for all recipients.
The launch also adds a new design to a field whose basic external setup has persisted for decades. Fan-Gang Zeng, a University of California, Irvine hearing researcher not affiliated with Med-El, said the launch could increase competition and encourage other manufacturers to develop similar products. Whether it does so remains to be seen.
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Decades of Work on Implant Design
Cochlear implants have been used since the 1980s to bypass damaged parts of the ear in people with severe-to-profound hearing loss. Their electrode arrays stimulate the auditory nerve, helping users perceive sound. Conventional systems depend on an external microphone and processor to capture and convert sound into signals for the implant.
Med-El CEO Ingeborg Hochmair said the idea of 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 the concept back. Gerhard Mark, the company’s senior research and development engineer and TICI Unico project leader, said the microphone posed the greatest engineering challenge because sound behaves differently as it passes through tissue. He did not disclose how the company addressed it.
Med-El says the TICI Unico followed more than 15 years of development. Its launch makes the system commercially available in Europe after regulatory approval there. The source report says it was not available in the United States at launch.
““For the first time, all components of a cochlear implant, including the microphone, are implanted beneath the skin.””
— Ingeborg Hochmair, Med-El CEO
med-el TICI Unico cochlear implant
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Trial Evidence and Long-Term Use
The available account does not give detailed trial results, such as the measures used to compare hearing performance or how results varied among participants. Med-El describes outcomes from its 30-patient trial as comparable to conventional implants, while further study results cited by the company have not yet undergone peer review. The size and duration of the published six-patient feasibility study also limit what can be concluded from it alone.
Long-term performance remains to be established in wider use. Med-El says data suggests the battery can support at least 24 hours of use per charge for at least 15 years, but the battery is not replaceable. The report does not specify what options patients would have if battery performance declines or the device needs repair. Availability beyond Europe, including a timeline for the United States, is also unclear.
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Availability and Follow-Up Results
The first commercial recipients will begin using the device outside the trial setting, while clinicians and researchers will be able to assess its performance in a broader group over time. Further peer-reviewed results cited by Med-El could provide more information about hearing outcomes and the device’s limits.
Med-El has not provided a United States availability date in the source report. Until one is announced, patients and clinicians there will need to wait for information on regulatory review and access. The company’s launch may prompt responses from other manufacturers, though no competing product or timetable is confirmed.
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Key Questions
What is the TICI Unico?
It is Med-El’s fully implanted cochlear implant, with its microphone, sound processor and battery beneath the skin and an electrode array in the cochlea.
How many patients have received it commercially?
Med-El said four commercial implantations were carried out on the morning of the launch announcement. The source report does not provide further details about those recipients.
Can users hear while swimming or asleep?
Med-El says the implant allows users to hear while asleep and swimming, and while the battery is being recharged. These are stated capabilities; individual experience may vary.
How long does the battery last?
Med-El says the rechargeable battery provides up to 40 hours per charge, with charging taking about one to one and a half hours. The company says performance data points to at least 24 hours of use per charge for at least 15 years. The battery cannot be replaced.
Is the device available in the United States?
No. The source report says the TICI Unico had European regulatory approval at launch but was not yet available in the United States. It gives no U.S. availability date.
Source: hn
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