Evaluation of the Baha SoundArc in children

Abstract

Objective: The Baha SoundArc coupling system has been developed as a non-surgical coupling of a Baha sound processor to the skull allowing the transfer of vibrational energy to the cochlear partition via bone conduction pathways. Today, there are several alternatives to this non-surgical approach as the Baha headband/test band, or the Baha Softband, or adhesive patches. Each of these current options have benefits and liabilities. The aim of the study was to evaluate pediatric experience and performance when using two non-surgical options, the Baha SoundArc compared to the Baha Softband.

Methods: Twenty-five children with unilateral mixed or conductive hearing loss aged 5-12 years of age evaluated the use of the Baha SoundArc compared to their existing Baha Softband in a one month take home trial. Participants had a minimum of 3 months experience using the control, Baha Softband. Participants were assessed at baseline and one month following fit of the Baha SoundArc. Measures included an experience and use patient reported outcome, speech perception testing in quiet using Phonetically Balanced Kindergarten (PBK) words, and sound field audiometry.

Results: Mean aided soundfield thresholds across the frequency range were 27.6 dB HL for Softband and 26.0 dB HL for SoundArc, which were not significantly different (P = >.05). Mean word recognition score was 80.8% when aided with the Softband device and 85.1% with the SoundArc, which was also not significantly different (P = >.05). Most children favored the aesthetics and usability of the SoundArc over Softband, but comfort ratings were largely similar for both devices.

Conclusions: Bone conduction sound processors mounted on a SoundArc or a Softband resulted in comparable improvements in aided thresholds and speech understanding in children suffering from conductive or mixed hearing loss. Both wearing modalities can be considered equivalent in terms of audiological outcomes, although both patients and clinicians preferred the usability and aesthetics of the SoundArc. The SoundArc provides an alternative wearing option for patients that may otherwise be discouraged by the aesthetics and usability of the Softband device.

Gov identifier: NCT03333577.

Keywords: Bone conduction hearing device; Hearing rehabilitation; Pediatric; Transcutaneous.