A Transcutaneous Active Middle Ear Implant (AMEI) in Children and Adolescents: Long-term, Multicenter Results

Abstract

Objective: Evaluation of the long-term safety and performance of an active middle ear implant (AMEI) in the treatment of hearing loss in children and adolescents with a primary focus on improvement in speech discrimination. Study Design: Prospective, multicentric, single-subject repeated-measures design in which each subject serves as his or her own control. Subjects: Thirty-one pediatric subjects aged 5 to 17 years. Intervention: Implantation of an active middle ear implant. Methods: Improvement in word recognition scores, speech reception thresholds (SRT) in quiet and noise, in addition to air conduction, bone conduction, and sound field thresholds were evaluated in two age groups. Results: Residual hearing did not change over time and speech intelligibility significantly improved and remained stable after 36 months. Children aged 5 to 9 improved in WRS from 21.92 to 95.38% and in SRT in quiet and in noise respectively from 62.45 dB SPL (sound pressure level) and +1.14 dB SNR to 42.07 dB SPL and −4.45 dB SNR. Adolescents aged 10 to 17 improved in WRS from 12.78 to 84.71% and in SRT in quiet and in noise respectively from 63.96 dB SPL and +3.32 dB SNR to 35.31 dB SPL and −4.55 dB SNR. Conclusions: The AMEI, under investigation, is a safe treatment for children and adolescents, and significantly improved audiological performance that remains stable on the long-term scale (up to 36 mo postimplantation). In general, all adult-related issues and questions regarding safety and performance can also be applied to the pediatric population, as no apparent specific issues developed.

Long-term Outcomes of Clip Coupler Implantation in Patients with Unilateral Congenital Aural Atresia

“…A recent multi-center study showed that the VSB is a safe and feasible device for children and adolescents with aural atresia, and can provide stable audiological performance in the long run. 31 Both the BB and the VSB have provided safety and excellent hearing benefit for patients with atresia. It is still not easy to choose which implantation method for patient with unilateral malformation will be the best.…”

Design and Development of the Vibrant Soundbridge – A 25-Year Perspective

“…Patient satisfaction and performance of the Soundbridge have been high and consistent across centres, countries, and continents [22][23][24][25][26][27]. In general, patients who wear the device all day (up to 16 h), report a natural sound quality, high device satisfaction, and a better ability to understand speech, especially in noisy environments [21].…”

Ergebnisse und Lebensqualität nach Implantation aktiver Mittelohrimplantate

“…In drei klinischen Studien wurde das Sprachverstehen mithilfe von alltagssimulierenden Satztests mit festem Störgeräuschpegel und adaptiven Sprachschallpegel (Oldenburger Satztest oder Oldenburger Kindersatztest) bewertet. Mit einer Verbesserung der SNR um 4–6 dB konnte auch hier der positive Versorgungseffekt bestätigt werden 99 101 104 .…”

“…5). Due to the low incidence of such malformations that amounts to 1:3,300-1:10,000 [94,95], the numbers of cases in clinical trials that focus on audiological outcomes after VSB implantation in children are often very low [96][97][98][99][100][101][102][103][104]. All currently available clinical trials (▶Table 6) could confirm a satisfactory speech recognition score in quiet of 80-100 % at 65 dB SPL.…”

“…Alle Patienten waren mit dem Hörimplantat zufrieden. Lediglich in den Subkategorien „Sprachverstehen im Störgeräusch“ und „Rückkopplung“ wurde keine Höchstpunktzahl erreicht 101 .…”