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

Magdalena Sereda*, Jeff Davies, Deborah A. Hall

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

11 Citations (SciVal)
2 Downloads (Pure)

Abstract

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.

Original languageEnglish
Pages (from-to)286-294
Number of pages9
JournalInternational Journal of Audiology
Volume56
Issue number4
Early online date25 Nov 2016
DOIs
Publication statusPublished - 3 Apr 2017

Keywords

  • clinical trials
  • combination device
  • feasibility
  • hearing aid
  • sound therapy
  • Tinnitus

ASJC Scopus subject areas

  • Language and Linguistics
  • Linguistics and Language
  • Speech and Hearing

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