Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant.

AIM: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.

Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults.

PURPOSE: Aim of the study was to evaluate the surgical, clinical and audiological outcome of 32 implantations of the Bonebridge, a semi-implantable transcutaneous active bone conduction implant. METHODS: In a retrospective cohort study, we analyzed data for 32 implantations in 31 patients (one bilateral case; seven age < 16 years) with conductive or mixed hearing loss, malformations, after multiple ear surgery, or with single-sided deafness as contralateral routing of signal (CROS). RESULTS: Four implantations were done as CROS. Five cases were simultaneously planned with ear prosthesis anchors, and 23 implantations (72%) were planned through three-dimensional (3D) "virtual surgery." In all 3D-planned cases, the implant could be placed as expected. For implant-related complications, rates were 12.5% for minor and 3.1% for major complications. Implantation significantly improved mean sound field thresholds from a preoperative 60 dB HL (SD 12) to 33 dB HL (SD 6) at 3 postoperative months and 34 dB HL (SD 6) at > 11 postoperative months (p < 0.0001). Word recognition score in quiet at 65 dB SPL improved from 11% (SD 20) preoperatively to 74% (SD 19) at 3 months and 83% (SD 15) at > 11 months (p < 0.0001). The speech reception threshold in noise improved from - 1.01 dB unaided to - 2.69 dB best-aided (p = 0.0018). CONCLUSION: We found a clinically relevant audiological benefit with Bonebridge. To overcome anatomical challenges, we recommend preoperative 3D planning in small and hypoplastic mastoids, children, ear malformation, and simultaneous implantation of ear prosthesis anchors and after multiple ear surgery.

Hearing rehabilitation after subtotal cochleoectomy using a new, perimodiolar malleable cochlear implant electrode array: a preliminary report.

PURPOSE: We here report about the first surgical experience and audiological outcome using a new, perimodiolar malleable cochlear implant electrode array for hearing rehabilitation after subtotal cochleoectomy for intralabyrinthine schwannoma (ILS). METHOD: Based on a cochlear implant with MRI compatibility of the magnet in the receiver coil up to 3 T, a cochlear implant electrode array was developed that is malleable and can be placed perimodiolar after tumor removal from the cochlea via subtotal cochleoectomy. Malleability was reached by incorporating a nitinol wire into the silicone of the electrode array lateral to the electrode contacts. The custom-made device was implanted in four patients with intracochlear, intravestibulocochlear or transmodiolar schwannomas. Outcome was assessed by evaluating the feasibility of the surgical procedure and by measuring sound field thresholds and word recognition scores. RESULTS: After complete or partial tumor removal via subtotal cochleoectomy with or without labyrinthectomy, the new, perimodiolar malleable electrode array could successfully be implanted in all four patients. Six months after surgery, the averaged sound field thresholds to pulsed narrowband noise in the four patients were 36, 28, 41, and 35 dB HL, and the word recognitions scores for monosyllables at 65 dB SPL were 65, 80, 70, and 25% (one patient non-German speaking). CONCLUSION: The surgical evaluation demonstrated the feasibility of cochlear implantation with the new, perimodiolar malleable electrode array after subtotal cochleoectomy. The audiological results were comparable to those achieved with another commercially available type of perimodiolar electrode array from a different manufacturer applied in patients with ILS.

How Much Cochlea Do You Need for Cochlear Implantation?

OBJECTIVE: To assess the efficacy of cochlear implantation (CI) after surgical removal of sporadic intracochlear or intravestibulocochlear schwannomas. STUDY DESIGN: Nonconcurrent cohort study. SETTING: Monocentric study at a tertiary referral center. PATIENTS: Patients with tumor resection and CI between 2011 and 2018 and a historic control group of CI patients matched by age, CI electrode type, and follow-up. INTERVENTIONS: Partial or subtotal cochleoectomy for tumor removal and single-stage CI. OUTCOME MEASURES: Main outcome measure: word recognition score for monosyllables in quiet at 65 dB SPL. RESULTS: Sixteen patients with tumor removal and CI (6 female, 10 male; mean age 55 ±â€Š14 years) and 16 control patients (6 female, 10 male; mean age 55 ±â€Š15 years) were identified. In the tumor group, surprisingly good word recognition scores were reached even after substantial structural defects in the cochlear capsule. While 12 months after cochlear implantation mean word recognition score for monosyllables in quiet was 58% (SD: 26) and 41% (SD: 26) in the control groups, it was 75% (SD: 19%) in the tumor group. CONCLUSIONS: In patients with intracochlear schwannomas, despite substantial structural damage to the cochlear capsule by partial or subtotal cochleoectomy, a tendency toward better performance with respect to word recognition with CI was observed as compared with other CI patients. The surprisingly good functional results despite substantial cochlear trauma may change clinical thinking with respect to cochlear implantation also beyond this special indication.

Measurement of implant stability and auditory pure-tone thresholds of Baha patients comparing osteosysthesis and osseointegrated systems.

With bone-anchored hearing systems the implant-bone junction is critical for the transmission of mechanical vibrations to the skull. The implant stability might differ between available and widely applied implants and can be estimated by resonance frequency analysis. The implant stability and the audiological performance of ten adult long-time users where a bone-anchored hearing system was connected by an Baha osseointegrated implant (Cochlear Ltd, Mölnlycke, Sweden) were compared with the implant stability of fourteen adult patients provided with a Ti-epiplating osteosysthesis system (Medicon, Tuttlingen, Germany). The acute implant stability was compared between these two implants with one cadaveric skull. The results show higher resonance frequencies and thus higher implant stability for the osseointegrating system of both, measuring acute and after long-time use of the implants. The audiological outcomes show frequency dependent differences between both systems as determined by comparing pure-tone bone-conduction audiometry. However, measuring thresholds by a direct stimulation of the implant reveals better hearing with low frequencies for the osseointegrated system and for high frequencies with the osteosysthesis system. At all, the implant selection has an impact on the implant stability and on the pure-tone hearing.

Functional results after Bonebridge implantation in adults and children with conductive and mixed hearing loss.

In patients with conductive hearing loss caused by middle ear disorders or atresia of the ear canal, a Bonebridge implantation can improve hearing by providing vibratory input to the temporal bone. The expected results are improved puretone thresholds and speech recognition. In the European Union, approval of the Bonebridge implantation was recently extended to children. We evaluated the functional outcome of a Bonebridge implantation for eight adults and three children. We found significant improvement in the puretone thresholds, with improvement in the air-bone gap. Speech recognition after surgery was significantly higher than in the best-aided situation before surgery. The Bonebridge significantly improved speech recognition in noisy environments and sound localization. In situations relevant to daily life, hearing deficits were nearly completely restored with the Bonebridge implantation in both adults and children.

Influence of implantable hearing aids and neuroprosthesison music perception.

The identification and discrimination of timbre are essential features of music perception. One dominating parameter within the multidimensional timbre space is the spectral shape of complex sounds. As hearing loss interferes with the perception and enjoyment of music, we approach the individual timbre discrimination skills in individuals with severe to profound hearing loss using a cochlear implant (CI) and normal hearing individuals using a bone-anchored hearing aid (Baha). With a recent developed behavioral test relying on synthetically sounds forming a spectral continuum, the timbre difference was changed adaptively to measure the individual just noticeable difference (JND) in a forced-choice paradigm. To explore the differences in timbre perception abilities caused by the hearing mode, the sound stimuli were varied in their fundamental frequency, thus generating different spectra which are not completely covered by a CI or Baha system. The resulting JNDs demonstrate differences in timbre perception between normal hearing individuals, Baha users, and CI users. Beside the physiological reasons, also technical limitations appear as the main contributing factors.

Timbre discrimination in cochlear implant users and normal hearing subjects using cross-faded synthetic tones.

The identification and discrimination of timbre are essential features of music perception in cochlear implant users. As timbre differences appear as multidimensional cues, the spectral shape, the spectral fluctuation, and the rise time are the most dominating parameters of timbre in normal hearing listeners. Recently, a psychoacoustical test was developed to determine the timbre discrimination abilities using only the spectral shape difference as a cue. Therefore, a synthetically generated tone continuum was used in an adaptive alternative forced choice paradigm. The spectral shape was modified by cross-fading the tones adaptively, depending on the listeners' response which allows very precise determinations of the just noticeable difference (JND). With this behavioral test, the spectral shape JND for complex tones with different fundamental frequencies was measured in cochlear implant users and compared to normal hearing listeners. The results confirm the applicability of the test to measure timbre discrimination in cochlear implant users. The resulting individual spectral shape JND profiles reveal a maximum with a fundamental frequency of 525 Hz, whereas the JND profiles were rather flat in the normal hearing individuals.

Auditory brainstem and cortical potentials following bone-anchored hearing aid stimulation.

Patients suffering from conductive or mixed hearing loss and Single-Sided Deafness may benefit from implantable hearing devices relying on bone conducted auditory stimulation. However, with only passively cooperative patients, objective methods are needed to estimate the aided and unaided pure-tone audiogram. This study focuses on the feasibility aspect of an electrophysiological determination of the hearing thresholds with bone-anchored hearing aid stimulation. Therefore, 10 normal-hearing subjects were provided with a Baha Intenso (Cochlear Ltd.) which was temporarily connected to the Baha Softband (Cochlear Ltd.). Auditory evoked potentials were measured by auditory stimulation paradigm used in clinical routine. The amplitudes, latencies, and thresholds of the resulting auditory brainstem responses (ABR) and the cortically evoked responses (CAEP) were correlated with the respective responses without the use of the Baha Intenso. The recording of ABR and CAEP by delivering the stimuli to the Baha results in response waveforms which are comparable to those evoked by earphone stimulation and appears appropriate to be measured using the Baha Intenso as stimulator. At the ABR recordings a stimulus artifact at higher stimulation levels and a constant latency shift caused by the Baha Intenso has to be considered. The CAEP recording appeared promising as a frequency specific objective method to approve the fitting of bone-anchored hearing aids. At all measurements, the ABR and CAEP thresholds seem to be consistent with the normal hearing of the investigated participants. Thus, a recording of auditory evoked potentials using a Baha is in general possible if specific limitations are considered.