title: Envoy Esteem Totally Implantable Hearing System: phase 2 trial, 1-year hearing results.
abstract: OBJECTIVE
  (1) To assess outcomes of the Envoy Esteem Totally Implantable Hearing System as measured by hearing results compared with preimplant baseline unaided (BLU) and best-fit aided conditions (BLA) and (2) to determine safety of the device.
  
  
  METHODS
  Prospective, nonrandomized, multicenter, subject-as-own-control, US Food and Drug Administration (FDA) trial.
  
  
  METHODS
  Private practice and hospital-based.
  
  
  METHODS
  Between January 2008 and August 2009, an FDA trial was performed at 3 sites. Fifty-seven subjects with bilateral, mild to severe sensorineural hearing loss, with discrimination greater than 40%, were implanted. Implanted components were (1) a sound processor and (2) 2 piezoelectric transducers (a sensor and a driver). A sound processor was implanted in the temporal bone. Transducers were coupled to the ossicles. Devices were activated 2 months postimplant. Hearing results were compared with ipsilateral BLU and BLA.
  
  
  RESULTS
  Speech reception thresholds (SRTs) improved from BLA of 41.2 dB to 29.4 dB with the Esteem (P ≤ .001). Word recognition score (WRS) at 50 dB hearing level (HL) improved from BLA of 46.3% to 68.9% with the Esteem. Pure tone averages improved by 27 ± 1 dB (confidence interval, 30-25). There were no changes in bone conduction. QuickSIN results showed no change. There were 6 serious adverse device effects: 2 wound infections (1 resolved medically, 1 required explantation), 1 delayed facial paralysis that resolved with medication, and 3 revisions due to limited benefit.
  
  
  CONCLUSIONS
  Phase 2 results at 12 months post implant demonstrated that (1) hearing results with the device are statistically superior to baseline best-fit hearing aids for SRT and WRS and (2) the device is safe.
authors.affiliation: The Ear Center of Greensboro, P.A., Greensboro, North Carolina, USA. emkraus@triad.rr.com
authors.forename: Eric M
authors.initials: EM
authors.lastname: Kraus
authors.forename: Jack A
authors.initials: JA
authors.lastname: Shohet
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Catalano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004429:Ear Ossicles / Q000601:surgery; D004869:Equipment Safety; D005158:Facial Paralysis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006310:Hearing Aids / Q000009:adverse effects; D006319:Hearing Loss, Sensorineural / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D017755:Prosthesis Fitting; D019919:Prosthesis Implantation / Q000009:adverse effects; D012086:Reoperation; D013063:Speech Discrimination Tests; D013069:Speech Reception Threshold Test; D013530:Surgical Wound Infection / Q000209:etiology; D013701:Temporal Bone / Q000601:surgery; D014159:Transducers; D055815:Young Adult