Clinical performance of a new magnetic bone conduction hearing implant system: Results from a prospective, multicenter, clinical investigation

Robert Briggs*, Andrew Van Hasselt, Michal Luntz, Marcos Goycoolea, Stina Wigren, Peter Weber, Henrik Smeds, Mark Flynn, Robert Cowan

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

61 Scopus citations

Abstract

The aim of the investigation was to prospectively evaluate, in a multicenter setting, the clinical performance of a new magnetic bone conduction hearing implant system. Methods: The test device was the Cochlear Baha Attract System (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden). Instead of the skin-penetrating abutment of traditional bone conduction hearing implants, the test device uses an implantable and an external magnet to transmit sound from the sound processor (SP) through intact skin to the skull bone. Twenty-seven adult patients with a conductive or mild mixed hearing loss or singlesided sensorineural deafness were included in the clinical investigation across four investigational sites. The patients were followed for 9 months after implantation. The study evaluated efficacy in terms of hearing performance compared with unaided hearing and with hearing with the SP on a softband. Patient benefit, soft tissue status, device retention, and safety parameters were monitored continuously throughout the investigation. Results: Surgery and healing was uneventful. Statistically significant improvements in audibility and speech understanding in noise and quiet were recorded for the test device compared with preoperative unaided hearing. Speech recognition was similar or better than tests performed with the same SP on a softband. Good soft tissue outcomes were reported, without major pressurerelated complications. At the end of the investigation, all patients continued to use and benefit from the device. Conclusion: The test device provides good hearing performance in patients with a conductive hearing loss or single-sided sensorineural deafness, with good wearing comfort and minimal soft tissue complications.

Original languageEnglish
Pages (from-to)834-841
Number of pages8
JournalOtology and Neurotology
Volume36
Issue number5
DOIs
StatePublished - 25 Jun 2015

Bibliographical note

Publisher Copyright:
© 2015 Otology and Neurotology, Inc.

Keywords

  • Baha.
  • Bone conduction
  • Bone conduction hearing implant
  • Boneanchored hearing aid
  • Clinical outcome
  • Hearing performance
  • Magnetic system
  • Osseointegration

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