Clinical Benefit of the Bonebridge in Single-Sided Deafness: Multi-Center Study Results after 24-Month Follow-Up

Aim The aim of this prospective study was to demonstrate the clinical benefit of the Bonebridge (BB) in patients with SSD over an observation period of 24 months.

Material and Methods: The study was performed witth 17 subjects at 5 tertiary referral hospitals in Switzerland and Germany. A within-subject repeated measures design was applied to assess speech intelligibility in noise and subjective benefit over a 24-month post-activation period at 5 time points (baseline, 6, 12, 18 and 24 months). Speech intelligibility was assessed in the aided and unaided conditions using a German matrix test (Oldenburg sentence test) with 3 test configurations: speech and noise from the front (S₀N₀), noise from the front with speech at the normal hearing side (S_NHN₀), and speech at the deaf side (S_SSDN₀). Device benefit was assessed using the Bern Benefit in SSD (BBSS) and the Speech, Spatial, and Qualities of Hearing (SSQ-B) questionnaires.

Results BB treatment improved speech intelligibility in noise of all subjects in the most difficult hearing situation (S_SSDN₀). By overcoming the head shadow, BB usage improved the speech reception thresholds by 1.7 dB (baseline, p=.001), 1.5 dB (6-month, p=.011), 1.8 dB (12-month, p=.001), 2.2 dB (18-month, p=.003), and 2.1 dB SNR (24-month, p=.004). In the other test situations, no improvement but also no deterioration of speech intelligibility was observed. A substantial and statistically significant device benefit was seen at all time points in the SSQ and BBSS scores. Safety of the device was confirmed by a lack of revision surgeries, serious device related adverse events or serious device deficiencies within the observation period.

Conclusions Our study data demonstrate the efficacy, safety and subject benefit of BB in adults with SSD.

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Artikel online veröffentlicht:
10. Juni 2020