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This funded research trial involving 14 adolescents, aged 10 to 17 years, in the Toronto Hospital for Sick Kids was carried out just prior to the new Osia implant obtaining FDA approval for use in the USA. The majority had congenital atresia with normal bone-conduction thresholds, the remainder had single-sided deafness. The concept of this new implant is that, unlike the BAHA attract device (for example) the Osia uses a stationary external device to communicate with an internal osseointegrated vibrator rather than the external device vibrating, thus aiming to reduce skin complications. It can make use of existing BAHA Connect/Attract osseointegrated implants in the bone for anchorage. It is most similar in terms of technology to the Mendel Bonebridge system but uses reverse piezo-electric energy to convert the electrical signal into vibration, rather than a mechanical device. The proposed advantages of the Osia over the Bonebridge relate to physical size of the device in the paediatric population and reduced fatigue of the mechanism over time. The results of this study revealed good improvement in functional hearing outcomes, with aided sound-field sound-field thresholds showing significantly improved thresholds across frequencies (p < 0.0001), including the high-frequencies, and speech understanding improved with all adolescents achieving highly accurate scores at up to six months post implantation. The children themselves reported continued improvements in their hearing for the full 12-month follow-up period. The two patients who experienced complications involved 1) difficulty in thinning a skin flap sufficiently in a child with morbid obesity, and 2) inflammation of the skin flap in a child who wore the device at night as well as during the day, which resolved with not wearing it while asleep and adjusting the magnet strength. The obvious limitations of this study are the bias due to the funded nature of the trial and conflict of interests of the authors (although they are respected in their field), and the small number of highly-selected candidates for inclusion in this non-randomised uncontrolled study. The next challenge for this device will be looking at outcomes in the much younger age range where this device may hold significant advantages possibly over existing devices.

First Generation Osseointegrated Steady State Implant Benefits in Children With Hearing Loss.
Gordon K, Papsin B, Feness M, et al.
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Aileen Lambert

Great Ormond Street Hospital, London, UK.

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