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.

Approximately 1 in 10 children with hearing loss is affected by auditory neuropathy spectrum disorder (ANSD). People who have ANSD usually have great difficulty understanding speech or communicating. However, it is possible for these patients to have audiograms that may indicate profound hearing loss up to normal hearing. This disorder is prognosed with positive, intact or present otoacoustic emissions (OAE) and/or cochlear microphonics (CM) as well as abnormal or absent auditory brainstem responses (ABR). Treatment methods include conventional hearing aids as well as cochlear implants. Cochlear implants (CI) usually promise better speech understanding for ANSD patients. We performed a systematic literature review aiming to show what improvements can effectively be achieved with cochlear implants in children with ANSD and compare this with our experience with two cases of ANSD implanted at our clinic. The retrospective review of two young CI patients diagnosed with ANSD during infancy demonstrated improvements over time in speech development communicated by their parents.

Objective: To confirm the long-term safety and performance of the Bonebridge BCI 602 in patients suffering from conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) over a 12-month period post-implantation. Study design: Multicentric, multinational, ambidirectional, observational Post-Market Clinical Follow-Up (PMCF) study. Setting: Eight tertiary referral hospitals. Participants: Fifty-two participants in 3 categories: adults CMHL (N=24), children CMHL (N=17), and SSD (N=11; 9 adults and 2 children). Intervention: Participants were implanted with the Bonebridge BCI 602 device. Main outcome measure(s): Outcome measures focused on sound field thresholds (SF), word recognition scores (WRS), speech reception thresholds (SRT) in both quiet and noise, adverse events, and subjective satisfaction (SSQ and AQoL questionnaires) at initial activation and at 3-month and 12-month post-implantation. Results: Safety was established by stable bone conduction (BC) thresholds and a low adverse event rate with no unanticipated events. Safety was underlined by clinically relevant improvements in the health-related assessment of Quality of Life (AQoL) questionnaire of mean+0.1 (adults and children CMHL) and +0.07 (SSD). Hearing significantly improved in sound field thresholds with mean functional gains of 24.05±8.68 dB (adults CMHL), 21.34±25.43 dB (children CMHL), and 32.89±25.87 dB (SSD). Mean word recognition scores improved by 65.83±28.62 percent points (PP) for adult CMHL and 65.77±27.53 PP for children CMHL and speech reception thresholds (SRT) in quiet by 15.4±9.34 dB and 19.96±14.66 dB, respectively. SRT in noise improved by −5.57±4.23 dB (adults; S _0° N _0° ), −5.12±5.08 dB (children, S _0° N _0° ), and −3.05±3.06 dB (SSD, S _SSD N _NH ). Subjective hearing ability tested with the Speech, Spatial, and Qualities (SSQ) of Hearing questionnaire improved and was clinically relevant for the adult (+2.23) and children (+1.51) CMHL groups. Conclusions: The Bonebridge BCI 602 demonstrates significant enhancements in hearing and speech understanding 12 months postoperatively, showing high user satisfaction and safety.