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Austrian company Med-El has launched the TICI Unico, which places a cochlear implant’s microphone and other components beneath the skin. The device received European regulatory approval, and four commercial implantations took place on the morning of the announcement. Med-El reports comparable hearing performance in a 30-patient clinical trial, but the device is not yet available in the United States.
Austrian medical-device company Med-El has launched the TICI Unico, a cochlear implant with its microphone, sound processor and battery implanted beneath the skin, and says it has received European regulatory approval. Four commercial implantations took place on the morning of the announcement, the company said, making the device a new option for people with severe-to-profound hearing loss who want to use a cochlear implant without wearing an external sound processor. It is not yet available in the United States.
Conventional cochlear implants use an external unit, usually worn behind the ear, to capture and process sound and send signals to an electrode array in the inner ear. Med-El’s TICI Unico moves those components under the skin. The company says its clinical trial of 30 patients found hearing performance comparable to its conventional implants. That result is a company-reported trial finding, not a claim that the device outperforms existing implants.
The implant weighs 20 grams and has four interconnected components: a small microphone beneath the scalp, a stimulator containing sound-processing hardware and a rechargeable lithium-ion battery, a coil for data transfer and charging, and a lead connected to the cochlear electrode array. The electrode array is the same type used in Med-El’s conventional devices, according to the report.
Users recharge the implant with a separate, car-key-size unit that attaches magnetically over the charging coil. Med-El says a charge takes about one to 1.5 hours and the battery is designed to last up to 40 hours per charge. The battery cannot be replaced. The company says its performance data indicates the device should maintain at least 24 hours of use per charge for 15 years; that is a projection, not a reported 15-year result.
Hearing Without an External Processor
The device changes how a cochlear implant is worn, rather than replacing the basic approach of stimulating the auditory system with an electrode array. Removing the external processor could reduce the need to take off or manage equipment during activities such as swimming and sleeping. Those uses matter because conventional external components can be inconvenient or vulnerable to slipping, pressure or loss.
The practical effects are still being assessed. In a six-patient feasibility study, University Hospital of Liège researcher Philippe Lefebvre said participants identified round-the-clock hearing as the main benefit, more than the device’s invisibility. Trial volunteer Diana Grosser described greater freedom in activities with her children, swimming and riding a motorcycle. These are individual accounts, not a guarantee that every recipient will have the same experience.
For the wider field, the launch introduces a commercially available design that attempts to address long-standing engineering challenges around placing the microphone and battery inside the body. University of California, Irvine researcher Fan-Gang Zeng said the launch could increase competition, though it remains unknown whether rival companies will develop comparable products or how quickly they might do so.
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From External Units to Implantation
Cochlear implants have been used since the 1980s to bypass damaged parts of the ear in people with severe-to-profound hearing loss. In a conventional system, a microphone and processor worn outside the body convert sound into signals sent through the scalp to an electrode array in the cochlea, the inner-ear structure that normally converts sound into neural signals.
Med-El CEO Ingeborg Hochmair said the idea of a fully implanted cochlear device dates to the 1970s, when she and her husband, Erwin, helped develop an early multichannel implant. She said progress was limited by microphone and battery technology. The company’s development of TICI Unico took more than 15 years, according to the report. Bringing a microphone beneath the scalp posed a particular challenge because sound behaves differently as it travels through tissue, said project leader Gerhard Mark.
Before the commercial launch, the device was studied in a small feasibility trial. Lefebvre led a six-patient study published in Communications Medicine the previous year. Med-El also cited a 30-patient clinical trial; details of that trial and its findings were not fully laid out in the supplied 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 CEO
Trial Evidence and Access Gaps
The available evidence does not establish how the implant performs for a broad population over many years. Med-El’s claim of comparable hearing performance is based on its 30-patient clinical trial, while the report also cites a published feasibility study involving six patients. The supplied information does not provide detailed trial results, participant characteristics or a direct comparison of outcomes across different groups. Hochmair said other studies found similar results, but those data were still awaiting peer review.
Long-term battery performance is also not yet demonstrated over the full period the company projects. The battery cannot be replaced, and Med-El’s statements about maintaining at least 24 hours of use per charge for 15 years are based on performance data, not 15 years of follow-up described in the report. The exact rollout schedule, cost, eligibility criteria and availability outside Europe are not specified. The device is not yet available in the United States.
Availability and Follow-Up Results
The immediate next step is the device’s rollout following its European approval and initial commercial implantations. Med-El has not provided, in the reported information, a timeline for U.S. availability or details of any U.S. regulatory application. People interested in the implant will need to check with hearing-care and implant teams about local access and suitability; the report does not give eligibility guidance.
Further clinical reporting and peer-reviewed results could clarify how hearing performance compares with conventional implants, how recipients use the device over time and whether the battery meets the company’s projected lifespan. The launch may also prompt responses from other implant makers, but no rival product or release timetable is confirmed in the source material.
Key Questions
What makes the TICI Unico different from a conventional cochlear implant?
Med-El says the microphone, sound processor and battery are implanted beneath the skin. Conventional implants use an external sound processor, typically worn behind the ear.
Has the implant reached patients?
Yes. Med-El said the device received European regulatory approval and that four commercial implantations took place on the morning of its launch announcement. A volunteer had also received it in 2024 as part of a clinical trial.
What has been reported about its hearing performance?
Med-El says its 30-patient clinical trial found performance comparable to its conventional implants. A separate six-patient feasibility study led by Philippe Lefebvre was published in Communications Medicine, according to the report. The supplied material does not include detailed results from the larger trial.
Can users hear while swimming or sleeping?
The fully implanted design removes the need to wear an external processor for listening, and Med-El says the device allows users to hear while asleep and swimming. A trial volunteer also described those activities as benefits. Individual results and practical use may vary; the report does not provide a detailed activity-use protocol.
Is the device available in the United States?
No U.S. availability is reported. The device has European regulatory approval, but the source says it is not yet available in the United States and gives no U.S. rollout timeline.
Source: hn
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