Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial.

Objective: 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.Design: Open and closed questions ad...

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Publicado en:International Journal of Audiology Vol. 56; no. 4; pp. 286 - 295
Autores principales: Sereda, Magdalena, Davies, Jeff, Hall, Deborah A.
Formato: questionnaire/scale research tables/charts Journal Article
Publicado: Taylor & Francis Ltd Apr2017
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Apr2017
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      pub: Taylor & Francis Ltd
      place: Philadelphia, Pennsylvania
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        10.1080/14992027.2016.1254822
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        atl: Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial.
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        au:
          Sereda, Magdalena
          Davies, Jeff
          Hall, Deborah A.
        affil: National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit, Nottingham, UK
      sug:
        subj:
          Tinnitus
          Hearing Aids
          Perceptual Masking
          Product Evaluation
          Human
          Questionnaires
          Male
          Middle Age
          Aged
          Descriptive Statistics
          Data Analysis Software
          Adverse Health Care Event
          Funding Source
          Middle Aged: 45-64 years
          Aged: 65+ years
          Male
      ab: Objective: 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.Design: 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.Study sample: Eight current combination hearing aid users (all males) aged between 62–72 years (mean age 67.25 years, SD = 3.8).Results: 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.Conclusions: A set of recommendations for future trials were formulated which calls for more “real world” trial design rather than tightly controlling the fitting procedure.
      pubtype: Academic Journal
      doctype:
        questionnaire/scale
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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