title: Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial.
abstract: This report considers feasibility of conducting a UK trial of combination devices for tinnitus, using data from the study which evaluated different listener programmes available within the pre-market version of Oticon Alta with Tinnitus Sound Generator.
  
  
  
  Open and closed questions addressed the following feasibility issues: (1) Participant recruitment; (2) Device acceptability; (3) Programme preferences in different self-nominated listening situations; (4) Usability; (5) Compliance; (6) Adverse events.
  
  
  
  Eight current combination hearing aid users (all males) aged between 62-72 years (mean age 67.25 years, SD = 3.8).
  
  
  
  All eight participants reported the physical aspects and noise options on the experimental device to be acceptable. Programmes with amplification and masking features were equally preferred over the basic amplification-only programme. Individual preferences for the different programme options varied widely, both across participants and across listening situations.
  
  
  
  A set of recommendations for future trials were formulated which calls for more "real world" trial design rather than tightly controlling the fitting procedure.
authors.affiliation: a National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit , Nottingham , UK and.|b Otology and hearing group, Division of Clinical Neuroscience , University of Nottingham , Nottingham , UK.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Sereda
authors.affiliation: a National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit , Nottingham , UK and.|b Otology and hearing group, Division of Clinical Neuroscience , University of Nottingham , Nottingham , UK.
authors.forename: Jeff
authors.initials: J
authors.lastname: Davies
authors.affiliation: a National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit , Nottingham , UK and.|b Otology and hearing group, Division of Clinical Neuroscience , University of Nottingham , Nottingham , UK.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Hall
mesh_terms: D000161:Acoustic Stimulation / Q000295:instrumentation*; D000368:Aged; D001307:Auditory Perception; D002986:Clinical Trials as Topic; D004867:Equipment Design; D005240:Feasibility Studies; D006309:Hearing; D006310:Hearing Aids; D006801:Humans; D008297:Male; D008875:Middle Aged; D009622:Noise; D057240:Patient Preference; D010470:Perceptual Masking; D012107:Research Design; D011795:Surveys and Questionnaires; D014012:Tinnitus / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Tinnitus; clinical trials; combination device; feasibility; hearing aid; sound therapy