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Published on: March 24, 2023
A New Transcutaneous Bone Conduction Hearing Implant: Short-term Safety and Efficacy in Children
Wolf-Dieter Baumgartner1, Jafar-Sasan Hamzavi, Klaus Böheim
1*Ear, Nose and Throat Department, University Clinic Vienna, Vienna†Ear, Nose and Throat Department, University Clinic St. Poelten, St. Poelten‡Ear, Nose and Throat Department, University Clinic Innsbruck, Innsbruck§Department for Hearing, Speech and Voice Disorders, University Clinic Innsbruck, Innsbruck||Ear, Nose and Throat Department, Krankenhaus der Elisabethinen, Graz, Austria.
Insights
This study shows a new bone conduction hearing implant is safe and effective for children with hearing loss. Speech perception significantly improved after implantation, with no damage to residual hearing.
Area of Science:
- Otolaryngology
- Audiology
- Biomedical Engineering
Background:
- Conductive or mixed hearing loss affects children, impacting speech perception.
- Bone conduction hearing implants offer a potential solution for hearing restoration.
Purpose of the Study:
- To evaluate the safety and efficacy of the Bonebridge transcutaneous bone conduction hearing implant (tBCI) in pediatric patients.
- To assess audiological outcomes and speech perception improvements over a 3-month follow-up period.
Main Methods:
- A prospective, single-subject repeated-measures design was employed.
- Twelve children (5-17 years) with conductive/mixed hearing loss received the tBCI.
- Audiometric thresholds and speech perception were measured preoperatively and at 1 and 3 months postoperatively.
Main Results:
- Significant improvements in speech perception (WRS and SRT50%) were observed 3 months post-implantation.
- Aided thresholds showed statistically significant improvement across tested frequencies.
- No significant changes in unaided hearing thresholds indicated preservation of residual hearing; only minor adverse events were reported.
Conclusions:
- The Bonebridge tBCI is a safe and effective option for improving hearing in children with conductive or mixed hearing loss.
- The implant demonstrates significant benefits in speech perception and audiological outcomes without compromising residual hearing.
Objective:
To investigate the safety and efficacy of a new bone conduction hearing implant in children, during a 3-month follow-up period.
Study Design:
Prospective, single-subject repeated-measures design in which each subject serves as his/her own control.
Setting:
Otolaryngology departments of four Austrian hospitals.
Patients:
Twelve German-speaking children aged 5 to 17 suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 4000 Hz.
Intervention:
Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI).
Main Outcome Measures:
The subjects' audiometric thresholds (air conduction, bone conduction, and sound field at frequencies 500 Hz to 8 kHz) and speech perception (word recognition scores [WRS] and 50% word intelligibility in sentences [SRT50%]) were tested preoperatively and at 1 and 3 months postoperatively. The patients were also monitored for adverse events and they or their parents filled out questionnaires to analyze satisfaction levels.
Results:
Speech perception as measured by WRS and SRT50% improved on average approximately 67.6% and 27.5 dB, respectively, 3 months after implantation. Aided thresholds also improved postoperatively, showing statistical significance at all tested frequencies. Air conduction and bone conduction thresholds showed no significant changes, confirming that subjects' residual unaided hearing was not damaged by the treatment. Only minor adverse events were reported and resolved by the end of the study.
Conclusion:
Safety and efficacy of the new bone conduction implant was demonstrated in children followed up to 3 months postoperatively.
