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

Sereda, Magdalena and Davies, Jeff and Hall, Deborah A. (2016) Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial. International Journal of Audiology . pp. 1-9. ISSN 1708-8186

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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.

Item Type: Article
Keywords: Tinnitus; clinical trials; combination device; feasibility; hearing aid; sound therapy
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine
Identification Number: https://doi.org/10.1080/14992027.2016.1254822
Depositing User: Sereda, Magdalena
Date Deposited: 01 Feb 2017 11:46
Last Modified: 01 Feb 2017 16:53
URI: http://eprints.nottingham.ac.uk/id/eprint/40194

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