Implantable Bone Conduction Devices Research Articles

Comparison of Transcutaneous and Percutaneous Implantable Hearing Devices for the Management of Congenital Aural Atresia: A Systematic Review and Meta-Analysis

Objective To compare audiometric outcomes, complications, and revisions required for percutaneous (pBCD) versus transcutaneous (tBCD) implantable bone-conduction devices for the treatment of hearing loss associated with congenital aural atresia (CAA). Databases Reviewed. PubMed, Scopus, CINAHL. Methods A systematic review was performed searching for English language articles from inception to December 14, 2022. Studies reporting audiometric outcomes or complications for either pBCDs or tBCDs for the treatment of CAA were selected for inclusion. A meta-analysis of single means and meta-analysis of proportions with comparison (Δ) of weighted proportions was conducted. Results A total of 56 articles with 756 patients were selected for inclusion. One hundred ninety patients were implanted with pBCDs, whereas the remaining 566 were implanted with tBCDs. Mean pure-tone audiometry improvement in the pBCD group (39.1 ± 1.1 dB) was significantly higher than in the tBCD group (34.6 ± 1.6 dB; Δ4.5 dB; 95% confidence interval, 4.2–4.7 dB; p < 0.0001). The average improvement in speech reception threshold was 38.6 ± 2.5 dB in the percutaneous group as compared with 32.7 ± 1.6 dB in the transcutaneous group (Δ5.9 dB [5.3–6.5 dB], p < 0.0001). Overall complication rates for patients implanted with pBCDs and tBCDs were 29.0% (15.7–44.4%) and 9.4% (6.5%–13.0%), respectively (Δ19.6% [12.0–27.7%], p < 0.0001). Conclusions Patients with CAA implanted with pBCDs had significantly better audiometric outcomes than those implanted with tBCDs. However, complication rates were significantly higher among the pBCD group.

Comparison of Outcomes of Surgery Versus Implantable Device for the Treatment of Hearing Loss Associated With Congenital Aural Atresia: A Systematic Review and Meta-Analysis.

To compare audiometric outcomes, complications, and revisions required for implantable bone-conduction devices (BCDs) versus atresia surgery for the treatment of hearing loss associated with congenital aural atresia. PubMed, Scopus, CINAHL. Databases were searched for English articles from inception to July 1, 2022, for studies reporting audiometric outcomes or complications for either BCDs or atresia surgery for the treatment of congenital aural atresia. Main outcome measures included pure-tone audiometry, air-bone gap, speech reception threshold, associated complications, and rates of revision for each treatment option. We identified 973 abstracts, of which 89 were selected for data extraction and analysis. A total of 2,611 patients were included, 1,901 in the atresia surgery group and 710 in the BCDs group. A meta-analysis of single means was conducted for age and audiometric outcomes, and a meta-analysis of proportions was conducted for complications and revisions. The average short-term improvement in pure-tone audiometry for the BCDs group was 34.4 ± 1.6 dB compared with 22.4 ± 1.5 dB for the atresia surgery group, representing a significant difference (12.0 dB; 95% confidence interval, 11.9-12.2; p < 0.0001). A smaller proportion of complications were reported in the devices group (16.9%) compared with the atresia surgery group (45.7%). In addition, a smaller proportion of cases in the devices group required some degree of revision (17.8%) compared with the atresia surgery group (23.0%). This study demonstrates that implantable BCDs have significantly better audiometric outcomes as well as a lower rate of complications and revisions required compared with atresia surgery.

EE521 Comparing the Cohort and Micro-Simulation Modeling Approaches in Cost-Effectiveness Modeling of Bone Conduction Implants (BCI): A Case Study of a Longitudinal Economic Analysis and a Markov Model-Based Simulation.

In the field of otorhinolaryngology, health economic evaluations are widely used to assess overall short- and long-term costs associated with implantable bone conduction devices (BCIs), as well as evaluating the clinical effectiveness of such systems. While longitudinal cohort analyses follow the same group of individuals over time, generating data representing large consecutive single-center patient cohorts, Micro-simulations are mostly applied following individuals through models when data is mainly generated from systematic reviews of peer-reviewed published literature, using best practices. The objective of this study was to investigate differences in outcomes either attributed to the longitudinal economic analysis cohort modeling approach or the Markov-model based microsimulation approach.

Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss.

Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care.

Audiological outcome measures with the BONEBRIDGE transcutaneous bone conduction hearing implant: impact of noise, reverberation and signal processing features

Objective: To assess the performance of an active transcutaneous implantable-bone conduction device (TI-BCD), and to evaluate the benefit of device digital signal processing (DSP) features in challenging listening environments.Design: Participants were tested at 1- and 3-month post-activation of the TI-BCD. At each session, aided and unaided phoneme perception was assessed using the Ling-6 test. Speech reception thresholds (SRTs) and quality ratings of speech and music samples were collected in noisy and reverberant environments, with and without the DSP features. Self-assessment of the device performance was obtained using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire.Study sample: Six adults with conductive or mixed hearing loss.Results: Average SRTs were 2.9 and 12.3 dB in low and high reverberation environments, respectively, which improved to −1.7 and 8.7 dB, respectively with the DSP features. In addition, speech quality ratings improved by 23 points with the DSP features when averaged across all environmental conditions. Improvement scores on APHAB scales revealed a statistically significant aided benefit.Conclusions: Noise and reverberation significantly impacted speech recognition performance and perceived sound quality. DSP features (directional microphone processing and adaptive noise reduction) significantly enhanced subjects’ performance in these challenging listening environments.

Comparison of Aided and Unaided Thresholds and Selection Processes of Contralateral Routing of Signal Hearing Aids and Implantable Bone Conduction Devices in Patients with Asymmetric Hearing Loss

Background and Objectives We reviewed the selection processes of contralateral routing of signal (CROS) hearing aids (HAs) and bone-conduction (BC) Has, and compared aided and unaided hearing thresholds. Subjects and Method Twenty-four patients with asymmetrical hearing loss who used BC HAs (n=12) and CROS HAs (n=12) were enrolled. The choice of two different HAs were compared with respect to the degree of hearing loss, the unaided hearing thresholds and functional gains. Results When the hearing thresholds of the better hearing ears were ＞30 dB HL, most (92%, 11 of 12) chose CROS rather than BC HAs, with significant difference (p=0.001). Both CROS and BC HAs groups showed significantly improved functional gains (46.6 dB and 53.4 dB, respectively). Aided air-conduction (AC) thresholds (40.2 dB HL) in the CROS group were similar to the AC thresholds (43.1 dB HL) of better hearing ears. However, the hearing threshold of Aided AC thresholds (35.8 dB HL) in BC HAs group were less than the BC thresholds (17.3 dB HL) of better hearing ears by 19 dB (p＜0.001). Conclusion Both groups showed significantly increased functional gains. CROS HAs were preferred when hearing thresholds in better hearing ears were ＞30 dB HL. The CROS group showed aided thresholds similar to the thresholds of better hearing ears, but the BC HAs group showed poorer aided thresholds than the thresholds of better hearing ears. For patients with asymmetric hearing loss, HAs should be selected based on the degree and types of hearing loss and the maximum output level of the selected device. Key words: Bone conduction ㆍ Contralateral routing of signal ㆍ Deafness ㆍ Hearing aids ㆍ Hearing loss ㆍ Single-sided

The current status and applications of implantable bone-conduction devices

Implantable bone-conduction devices are characterized by the fact that the vibration is transmitted through bone conduction. The technology and surgical techniques in the application of implantable bone-conduction devices have developed considerably in recent years, experiencing a transformation from percutaneous to transcutaneous implantation. This article reviewed current developments in the types, surgical indications, and complications, as well as compared between the various bone-conduction devices to provid references for clinical application.

Comparison of 2 Implantable Bone Conduction Devices in Patients With Single-Sided Deafness Using a Daily Alternating Method

Comparison of the auditory and subjective capabilities of 2 implantable bone conduction devices BAHA Divino sound processor (Divino) and the BAHA BP100 sound processor (BP100) using a daily alternating method. Open prospective comparative trial. Tertiary referral otology and neurotology center. Ten patients with single-sided deafness (SSD) using a Divino for more than 1 year. The patients with SSD changed to the BP100 for 1 week, and then underwent an evaluation period of 18 days switching between BP100 and Divino on a daily alternating basis. On a scale from 0 to 10, patients rated their quality of hearing daily with both devices concerning overall satisfaction, clearness of sound, and effort of listening in background noise. For the total duration of the trial, the spatial hearing questionnaire (SHQ) and the abbreviated profile of hearing aid benefit (APHAB) were administered. In the unaided condition and with Divino at baseline and aided with BP100 after the evaluation period, adaptive speech in quiet and in noise testing was performed with speech and noise coming from different azimuth angles. Subjective rating in a diary, APHAB, SHQ, and aided speech in quiet and speech in noise. The diary shows significant improvement on all subscales with BP100 in comparison with Divino. These differences did not change significantly during 18 days. On the APHAB, listening in background noise and in reverberant conditions was rated significantly better with the BP100. The SHQ shows a significant difference between both devices on all subscales except for source localization and speech understanding in quiet. Speech audiometry showed a significant head shadow benefit with both implantable bone conduction devices (median [Q1, Q3]: Divino = 2.67 dB [0.33, 1.51], BP100 = 2.83 dB [4.08, 3.83]). There was no significant difference found between both devices. Both the Divino and the BP100 reduce the handicap experienced by patients with SSD. Subjective assessment using a daily alternating method shows higher overall hearing capabilities with BP100. Results of the questionnaires are similar. Speech audiometry in noise does not reveal a statistically significant difference between both devices. A daily alternating method can provide useful information for both the patient and the audiologist because objective measurements do not show any statistically significant differences between patients. In our opinion, daily alternation of devices is a useful method to compare different devices.

Output Vibration Measurements of Bone-Anchored Hearing Aids

Hypothesis: Different bone-anchored hearing aids (BAHAs) processors have different output vibration characteristics, which depend on the mechanical load and the volume setting. Responses will differ between live heads and dry or plastic skulls. Background: The BAHA is an implantable bone-conduction device. Three different BAHA models are available. Their output vibrations have not been reported using a noncontact method with differing impedance loads, including the BAHA-fitted patient head. Methods: Using a laser-Doppler vibrometer, vibration responses with sound input of 70- to 80-dB sound pressure level were measured on unloaded BAHAs, a dry skull, a plastic skull, and on the abutments of three live BAHA-fitted patients. Responses at different volume settings and distances from the vibrator were also tested. Frequency responses were calculated for displacement, velocity, and acceleration. Results: Unloaded BAHA accelerations were approximately 30 to 50 dB higher than live-head accelerations. Live-head accelerations were similar to dry skulls in frequencies of more than 500 Hz, but much higher than the plastic skull responses. Live-head responses were more damped. The Cordelle II outperformed the other two processors by approximately 20 dB. The Classic 300 had better low-frequency responses than the Compact. The volume settings had little effect on vibration output overall. Acceleration peak was at approximately 2.5 kHz for all conditions. Conclusion: The BAHA processors differ in the output acceleration they can achieve with differing loads. The volume control setting has little impact on accelerations produced for most processors. The live-head responses are similar to the dry skull in frequencies of more than 500 Hz.

Output Vibration Measurements of Bone-Anchored Hearing Aids

Different bone-anchored hearing aids (BAHAs) processors have different output vibration characteristics, which depend on the mechanical load and the volume setting. Responses will differ between live heads and dry or plastic skulls. The BAHA is an implantable bone-conduction device. Three different BAHA models are available. Their output vibrations have not been reported using a noncontact method with differing impedance loads, including the BAHA-fitted patient head. Using a laser-Doppler vibrometer, vibration responses with sound input of 70- to 80-dB sound pressure level were measured on unloaded BAHAs, a dry skull, a plastic skull, and on the abutments of three live BAHA-fitted patients. Responses at different volume settings and distances from the vibrator were also tested. Frequency responses were calculated for displacement, velocity, and acceleration. Unloaded BAHA accelerations were approximately 30 to 50 dB higher than live-head accelerations. Live-head accelerations were similar to dry skulls in frequencies of more than 500 Hz, but much higher than the plastic skull responses. Live-head responses were more damped. The Cordelle II outperformed the other two processors by approximately 20 dB. The Classic 300 had better low-frequency responses than the Compact. The volume settings had little effect on vibration output overall. Acceleration peak was at approximately 2.5 kHz for all conditions. The BAHA processors differ in the output acceleration they can achieve with differing loads. The volume control setting has little impact on accelerations produced for most processors. The live-head responses are similar to the dry skull in frequencies of more than 500 Hz.