title: Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation.
abstract: OBJECTIVE
  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 single-sided 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 pressure-related complications. At the end of the investigation, all patients continued to use and benefit from the device.
  
  
  CONCLUSIONS
  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.
authors: *HEARing Cooperative Research Centre, Melbourne, Australia; †Chinese University of Hong Kong, Hong Kong, China; ‡Bnai Zion Hospital, Haifa, Israel; §Clínica Las Condes, Santiago, Chile; ∥Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden; and ¶Cochlear Americas, Denver, Colorado, U.S.A.
authors: Robert
authors: R
authors: Briggs
authors: Andrew
authors: A
authors: Van Hasselt
authors: Michal
authors: M
authors: Luntz
authors: Marcos
authors: M
authors: Goycoolea
authors: Stina
authors: S
authors: Wigren
authors: Peter
authors: P
authors: Weber
authors: Henrik
authors: H
authors: Smeds
authors: Mark
authors: M
authors: Flynn
authors: Robert
authors: R
authors: Cowan
mesh_terms: D000328:Adult; D000368:Aged; D001844:Bone Conduction; D005260:Female; D006309:Hearing; D006310:Hearing Aids; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000628:therapy*; D046088:Hearing Loss, Unilateral / Q000628:therapy*; D006320:Hearing Tests; D006801:Humans; D060328:Magnetic Phenomena; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013067:Speech Perception; D053441:Suture Anchors; D013548:Sweden; D055815:Young Adult