title: The bone conduction implant: Clinical results of the first six patients.
abstract: OBJECTIVE
  To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin.
  
  
  METHODS
  A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device.
  
  
  METHODS
  Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss.
  
  
  RESULTS
  The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses.
  
  
  CONCLUSIONS
  The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.
authors.affiliation: * Department of Signals and Systems, Chalmers University of Technology , Gothenburg , Sweden.
authors.forename: Sabine
authors.initials: S
authors.lastname: Reinfeldt
authors.forename: Bo
authors.initials: B
authors.lastname: Håkansson
authors.forename: Hamidreza
authors.initials: H
authors.lastname: Taghavi
authors.forename: Karl-Johan
authors.initials: KJ
authors.lastname: Fredén Jansson
authors.forename: Måns
authors.initials: M
authors.lastname: Eeg-Olofsson
mesh_terms: D000161:Acoustic Stimulation / Q000295:instrumentation / Q000379:methods; D000293:Adolescent; D000328:Adult; D000368:Aged; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold; D001844:Bone Conduction / Q000502:physiology*; D012048:Correction of Hearing Impairment / Q000295:instrumentation*; D005260:Female; D006314:Hearing Loss, Conductive / Q000503:physiopathology / Q000523:psychology / Q000534:rehabilitation*; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000503:physiopathology / Q000523:psychology / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058117:Neural Prostheses; D009622:Noise; D011788:Quality of Life; D059629:Signal-To-Noise Ratio; D013067:Speech Perception / Q000502:physiology; D016896:Treatment Outcome; D055815:Young Adult
keywords: Bone conduction implant; active transcutaneous; audiometry; hearing loss; intact skin; patient related outcome measure; questionnaires