Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six‐month results from a multicentre study

Abstract

Objectives:To compare the hearing performance of patients with conductive and mild mixed hearing loss and single-sided sensorineural deafness provided with a new transcutaneous bone conduction hearing implant (the Baha Attract System) with unaided hearing as well as aided with a sound processor on a softband. Furthermore, to evaluate safety and subjective benefit before and after implantation of the test device.Participants: Fifty-four adult patients in five participating centres were enrolled in this prospective study. Baseline data were collected during a pre-operative visit, and after a softband trial, all patients were implanted unilaterally. Follow-up visits were scheduled at 10 days, 4, 6, 12 weeks and 6 months. Main outcome measures.Free-field hearing thresholds pure-tone average (PTA4 in dB HL; mean threshold at 500, 1000, 2000, 4000 Hz; primary outcome measure). Individual free-field hearing thresholds, speech recognition in quiet and in noise, soft tissue status during followup and subjective benefit as measured with the Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech, Spatial and Qualities of Hearing Scale (SSQ) and Health Utilities Index (HUI) questionnaires.Results: Implantation of the Baha Attract System resulted in favourable audiological outcomes compared to unaided conditions. On the primary outcome parameter, a statistically significant improvement was observed compared to unaided hearing for the patients with conductive/mixed hearing loss (mean PTA4 difference −20.8 dB HL, SD 9.8; P < 0.0001) and for the patients with single-sided sensorineural deafness (SSD) (mean PTA4 difference −21.6 dB HL, SD 12.2; P < 0.0001). During all audiology tests, the non-test ear was blocked. Statistically significant improvements were also recorded in speech tests in quiet and noise compared to unaided hearing for the conductive/mixed hearing loss group and for speech in quiet in the SSD group. Compared to the pre-operative measurement with softband, no significant differences were recorded in the PTA4 free-field hearing threshold or the other audiological outcomes in either of the groups (P > 0.05). Soft tissue-related issues observed during follow-up included numbness, pain/discomfort at the implant site and to a lesser extent pressure-related skin complications. A declining trend was

Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing

“…For the total cohort, the statistically significant improvement in audiological outcomes recorded at 6 months of follow-up as reported by den Besten et al ( 11 ) was maintained also at 12 and 24 months and was numerically similar to the 6-month results. The mean improvement from baseline unaided PTA4 to the aided value at 24-month was –21.5 dB (SD 8.3, range, –45.0 to –3.8 dB, n = 46, p ≤ 0.0001).…”

“…The mean improvement from baseline unaided PTA4 to the aided value at 24-month was –21.5 dB (SD 8.3, range, –45.0 to –3.8 dB, n = 46, p ≤ 0.0001). The mean improvement in speech recognition in noise at 24 months was –4.47 dB signal-to-noise ratio SNR (SD 6.11, range –25.2–4.20, n = 31, p ≤ 0.0001); data from two sites were excluded from the analysis due to invalid results for this specific test, as elaborated in den Besten et al ( 11 ). In speech tests in quiet the mean improvement in % correctly repeated words from unaided to 24-month aided hearing was 40.4% at 50 dB SPL (SD 33.3, range, –65.0–90.0, n = 46, p ≤ 0.0001), 43.3% at 65 dB SPL (SD 29.9, range, –10.0–90.0, n = 46, p ≤ 0.0001) and 14.0% at 80 dB SPL (SD 20.7, range, –10.0 to 71.0, n = 46, p ≤ 0.0001).…”

“…Follow-up visits were scheduled at 10 days; 4, 6, and 12 weeks; 6, 12, and 24 months after surgery. The sample size was calculated for improvement in audiometric thresholds pure-tone average PTA4 (mean of 500, 1000, 2000, and 4000 Hz) compared with the preoperative unaided hearing condition for the whole study population; for details, see den Besten et al ( 11 ). Furthermore, a subgroup analysis per type of hearing loss (CHL/MHL and SSD) was performed.…”

“…In case of significantly better hearing in the contralateral ear, data were obtained with the better ear blocked. Audiometric methods are described in detail in den Besten et al ( 11 ).…”

“…The primary aim of this multicenter study was to evaluate efficacy in terms of hearing performance of a transcutaneous implant for bone conduction hearing after 6 months of follow-up, as previously reported by den Besten et al ( 11 ). The aim of this paper was to evaluate the long-term audiological and clinical performance after a total of 2 years of follow-up in the same population, and to compare patient-reported outcomes (PROs) over time.…”