title: Phase 1 clinical trial results of the Envoy System: a totally implantable middle ear device for sensorineural hearing loss.
abstract: OBJECTIVE
  This report will present the results of the USA Phase 1 clinical trials for the Envoy System (St. Croix Medical): A totally implantable middle ear hearing system for sensorineural loss.
  
  
  METHODS
  A prospective, single-subject, repeated-measures, multicenter study was performed to evaluate safety and functionality of the Envoy System. Data collected included Abbreviated Profile of Hearing Aid Benefit, bone conduction threshold, speech reception threshold, functional gain, word recognition, and adverse events. Testing was performed unaided, with the patient's best-fit hearing aid, and post device activation at 2 (trial endpoint) and 4 months.
  
  
  RESULTS
  Five of 7 patients at the 2-month postactivation period had working systems. All 5 patients perceived benefit increases with the Envoy System over their best-fit hearing aid, including communication in high background noise levels. Word recognition was improved over hearing aids. Functional gain and speech reception thresholds were similar for the Envoy device and hearing aids.
  
  
  CONCLUSIONS
  The feasibility trial has shown the Envoy device, a totally implantable middle ear device, can safely sense and drive the ossicular chain.
  
  
  METHODS
  B-2.
authors.affiliation: Pittsburgh Ear Associates, Allegheny General Hospital, Department of Otolaryngology, University of Pittsburgh Medical Center, Pennsylvania, USA. www.pghear@aol.com
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Chen
authors.forename: Douglas D
authors.initials: DD
authors.lastname: Backous
authors.forename: Moisés A
authors.initials: MA
authors.lastname: Arriaga
authors.forename: Renee
authors.initials: R
authors.lastname: Garvin
authors.forename: Deborah
authors.initials: D
authors.lastname: Kobylek
authors.forename: Thomas
authors.initials: T
authors.lastname: Littman
authors.forename: Sue
authors.initials: S
authors.lastname: Walgren
authors.forename: David
authors.initials: D
authors.lastname: Lura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001299:Audiometry / Q000379:methods; D004599:Electric Stimulation Therapy / Q000295:instrumentation; D005240:Feasibility Studies; D005260:Female; D006310:Hearing Aids; D006319:Hearing Loss, Sensorineural / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D011446:Prospective Studies; D019736:Prostheses and Implants; D013813:Therapy, Computer-Assisted / Q000379:methods; D016896:Treatment Outcome