Multicenter Results With an Active Transcutaneous Bone Conduction Implant in Patients With Single-sided Deafness

Huber, Alexander; Strauchmann, Bernd; Caversaccio, Marco; Wimmer, Wilhelm; Linder, Thomas; Min, Nicola De; Hempel, John Martin; Pollotzek, Marlene; Frenzel, H; Hanke, Frauke; Röösli, Christof

doi:10.1097/mao.0000000000003418

Cited by 12 publications

(14 citation statements)

References 46 publications

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“…6 b). This outcome is comparable to the average improvements reported for the BCI 601 in a similar setup (S SSD N0°), with a range of + 0.3 to − 2.5 dB [ 11 , 40 , 53 , 61 – 64 ].…”

Section: Discussionsupporting

confidence: 83%

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

Sprinzl

Toner²,

Koitschev

et al. 2023

Eur Arch Otorhinolaryngol

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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.

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“…6 b). This outcome is comparable to the average improvements reported for the BCI 601 in a similar setup (S SSD N0°), with a range of + 0.3 to − 2.5 dB [ 11 , 40 , 53 , 61 – 64 ].…”

Section: Discussionsupporting

confidence: 83%

“…This may be attributed to the normal-hearing ear in SSD patients. Wearing times of ~ 8 h for the BCI 601 in SSD patients are reported 2 years after surgery [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

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

Sprinzl

Toner²,

Koitschev

et al. 2023

Eur Arch Otorhinolaryngol

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“…However, these strategies do not yield improvement in localization, binaural summation, or binaural squelch, which are important for speech understanding in background noise, a common complaint of those with SSD 2 . CROS‐HA and BCHD devices provide only moderate benefits for speech understanding in spatially‐separated speech and noise when the signal is directed at the poorer‐hearing ear and/or the noise is directed to the better‐hearing ear 3–6 …”

Section: Introductionmentioning

confidence: 99%

Cochlear Implants for Single‐Sided Deafness: Quality of Life, Daily Usage, and Duration of Deafness

et al. 2022

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ObjectiveTo report our experience for adults undergoing cochlear implantation (CI) for single‐sided deafness (SSD).MethodsThis is a retrospective case series for adults with SSD who underwent CI between January 2013 and May 2021 at our institution. CNC and AzBio speech recognition scores, Tinnitus Handicap Inventory (THI), Speech, Spatial, and Qualities of Hearing Scale (SSQ12), datalogging, and the Cochlear Implant Quality of Life (CIQOL)‐10 Global measure were utilized.ResultsSixty‐six adults underwent CI for SSD (median 51.3 years, range 20.0–74.3 years), and 57 (86.4%) remained device users at last follow‐up. Compared to pre‐operative performance, device users demonstrated significant improvement in speech recognition scores and achieved peak performance at six months post‐activation for CNC (8.0% increased to 45.6%, p < 0.0001) and AzBio in quiet (12.2% increased to 59.5%, p < 0.0001). THI was decreased at 6 months post‐implantation (58.1–14.6, p < 0.0001), with 77% of patients reporting improved or resolved tinnitus. Patients demonstrated improved SSQ12 scores as well as the disease‐specific CIQOL‐10 Global questionnaire. Duration of deafness was not associated with significant differences in speech recognition performance. Average daily wear time was positively associated with CNC and AzBio scores as well as post‐operative CIQOL‐10 scores.ConclusionsHerein we present the largest cohort of adult CI recipients with SSD with data on speech recognition scores, tinnitus measures, and SSQ12. Novel insights regarding the correlation of datalogging, duration of deafness, and CI‐specific quality of life (CIQOL‐10) metrics are discussed. Data continue to support CI as an efficacious treatment option for SSD.Level of Evidence4 Laryngoscope, 133:2362–2370, 2023

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“…One option available is the BONEBRIDGE system (MED-EL, Innsbruck, Austria), an active transcutaneous bone conduction implant [7]. It is indicated for the treatment of patients with SSD as well as conductive or mixed hearing loss [8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Performance with a new bone conduction implant audio processor in patients with single-sided deafness

Wimmer

Zbinden

Gawliczek

et al. 2023

Eur Arch Otorhinolaryngol

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Purpose The SAMBA 2 BB audio processor for the BONEBRIDGE bone conduction implant features a new automatic listening environment detection to focus on target speech and to reduce interfering speech and background noises. The aim of this study was to evaluate the audiological benefit of the SAMBA 2 BB (AP2) and to compare it with its predecessor SAMBA BB (AP1). Methods Prospective within-subject comparison study. We compared the aided sound field hearing thresholds, speech understanding in quiet (Freiburg monosyllables), and speech understanding in noise (Oldenburg sentence test) with the AP1 and AP2. Each audio processor was worn for 2 weeks before assessment and seven users with single-sided sensorineural deafness (SSD) participated in the study. For speech understanding in noise, two complex noise scenarios with multiple noise sources including single talker interfering speech were used. The first scenario included speech presented from the front (S0NMIX), while in the second scenario speech was presented from the side of the implanted ear (SIPSINMIX). In addition, subjective evaluation using the SSQ12, APSQ, and the BBSS questionnaires was performed. Results We found improved speech understanding in quiet with the AP2 compared to the AP1 aided condition (on average + 17%, p = 0.007). In both noise scenarios, the AP2 lead to improved speech reception thresholds by 1.2 dB (S0NMIX, p = 0.032) and 2.1 dB (SIPSINMIX, p = 0.048) compared to the AP1. The questionnaires revealed no statistically significant differences, except an improved APSQ usability score with the AP2. Conclusion Clinicians can expect that patients with SSD will benefit from the SAMBA 2 BB by improved speech understanding in both quiet and in complex noise scenarios, when compared to the older SAMBA BB.

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Multicenter Results With an Active Transcutaneous Bone Conduction Implant in Patients With Single-sided Deafness

Cited by 12 publications

References 46 publications

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

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

Cochlear Implants for Single‐Sided Deafness: Quality of Life, Daily Usage, and Duration of Deafness

Performance with a new bone conduction implant audio processor in patients with single-sided deafness

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