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Med-El has launched the TICI Unico, which the company describes as the first commercially available cochlear implant with all components beneath the skin. The device has European regulatory approval, and four commercial implantations were performed on launch day; it is not yet available in the United States. Early clinical findings reported comparable hearing performance to conventional implants, but broader results and long-term outcomes remain to be established.
Austrian medical-device company Med-El has launched the TICI Unico, a cochlear implant with its microphone, sound processor and other components implanted beneath the skin. The company says the device has European regulatory approval, and four commercial implantations were performed on the morning of its launch; it is not yet available in the United States.
Conventional cochlear implants use an external unit worn behind the ear. That unit contains a microphone, processor and battery, and sends signals through the skin to an electrode array in the cochlea, the inner-ear structure that helps convert sound into signals for the nervous system. The TICI Unico moves the system’s components under the skin, eliminating the need to wear or remove an external sound processor. Med-El says this design can let users hear while sleeping or swimming, and while the implant is recharging, although the report does not detail how hearing is maintained during charging.
The 20-gram device comprises four connected components. A small microphone sits about 6 millimeters beneath the scalp and connects to a stimulator containing sound-processing hardware and a rechargeable lithium-ion battery. A coil transfers data and power through the skin, while a lead connects the system to an electrode array in the cochlea. The array is the same type used in Med-El’s conventional implants. A magnetic, car-key-size unit called a GoPod attaches over the charging coil to recharge the device.
Med-El says a full charge takes about one to 1.5 hours, and the battery is designed to provide up to 40 hours of use per charge. The company also says performance data indicates it should maintain at least 24 hours of use per charge for at least 15 years. Those figures are company projections; the battery cannot be replaced, and the report does not provide independent long-term data confirming the projected performance.
Hearing Without an External Processor
The launch offers some cochlear implant users a different way to manage a device they rely on: there is no external processor to wear, remove or keep in place. That could matter during activities in which an external unit can be inconvenient, including swimming and riding a motorcycle, and may allow hearing access at times conventional users take their processors off, such as at night. The change is also intended to address the visibility and stigma some users associate with externally worn equipment.
Early evidence is encouraging but limited. Med-El says a clinical trial involving 30 patients 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, also said clinical results so far suggest comparable performance. These reports do not establish how the device will perform across a wider patient population or over many years. The implant’s fixed battery and the need for a surgical procedure are also relevant considerations for patients and clinicians.
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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 for people with severe-to-profound hearing loss. In a conventional system, an external processor captures sound and sends electrical signals to electrodes implanted in the cochlea. The TICI Unico uses the same type of cochlear electrode array, but relocates the microphone and processing system under the skin.
Med-El CEO Ingeborg Hochmair said the goal of a fully implanted system dates to the 1970s, when microphone and battery technology were not adequate for the task. The company says development of this device took more than 15 years. Gerhard Mark, Med-El’s senior research and development engineer and the project leader, identified the implanted microphone as the largest engineering challenge because sound behaves differently as it travels through tissue.
The company’s launch follows earlier clinical work. Lefebvre led a six-patient feasibility study published last year in the journal Communications Medicine. Med-El has also cited other studies with similar results, but Hochmair said that data is still awaiting peer review. The report does not provide the studies’ full methods or detailed performance measurements.
“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 CEO
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Performance and Access Still Unsettled
The launch establishes that the device has European regulatory approval and that four commercial implantations took place on announcement day. It does not establish how widely the system will be adopted, when it may be available in other markets or whether it will receive approval in the United States. Med-El has not given a U.S. availability date in the source report.
Questions also remain about evidence and long-term use. The company’s 30-patient trial is reported to have found comparable hearing performance, but detailed results are not included in the source material. Some additional results cited by Hochmair were still awaiting peer review. The report does not specify the trial’s duration, patient characteristics, exact comparisons or potential complications. It also does not establish whether the projected battery life will match real-world performance over 15 years.
Med-El did not disclose how its engineers addressed the microphone’s challenges under the scalp. The device’s battery cannot be replaced, and the source report does not explain what replacement or revision procedures might involve if its performance changes over time.
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More Clinical Data and Market Rollout
The immediate next step is the device’s clinical and commercial rollout in Europe, following regulatory approval and the first four commercial implantations. The source report does not provide a schedule for further procedures, a price, or details about which patients will be eligible.
Additional published clinical results could help clarify how closely hearing performance matches conventional implants, how patients experience daily use and how well the battery projections hold up. Med-El’s other cited study results are awaiting peer review, according to Hochmair. U.S. availability remains a separate open question: the device was not available there at the time described, and no approval timetable was reported.
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Key Questions
What is the TICI Unico?
It is Med-El’s fully implanted cochlear implant, with the microphone, sound processor, battery and other components placed beneath the skin. It connects to an electrode array in the cochlea.
Has the device reached patients?
Yes. The source report says four commercial implantations were performed on the morning Med-El announced the launch. A volunteer had also received the device in 2024 as part of a clinical trial.
Where is the implant available?
Med-El said the device had European regulatory approval. It was not yet available in the United States at the time covered by the report, and no U.S. availability date was given.
How long does its battery last?
Med-El says the rechargeable battery can provide up to 40 hours per charge, which takes about one to 1.5 hours. The company says performance data indicates at least 24 hours of use per charge for at least 15 years; those are company projections, and the battery cannot be replaced.
Has it been shown to work as well as conventional implants?
Med-El says a 30-patient clinical trial found comparable hearing performance. A separate six-patient feasibility study leader also described early results as comparable. The source report does not provide detailed trial measurements, and further evidence is needed to judge longer-term performance.
Source: hn
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