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

Sereda, Magdalena; Davies, Jeff; Hall, Deborah A.

Authors

Jeff Davies JEFF.DAVIES@DMU.AC.UK

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DEBORAH HALL Deborah.Hall@nottingham.ac.uk
Professor of Hearing Sciences



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.

Citation

Sereda, M., Davies, J., & Hall, D. A. (in press). 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, https://doi.org/10.1080/14992027.2016.1254822

Journal Article Type Article
Acceptance Date Oct 25, 2016
Online Publication Date Nov 25, 2016
Deposit Date Feb 1, 2017
Publicly Available Date Feb 1, 2017
Journal International Journal of Audiology
Print ISSN 1499-2027
Electronic ISSN 1708-8186
Publisher Taylor & Francis Open
Peer Reviewed Peer Reviewed
DOI https://doi.org/10.1080/14992027.2016.1254822
Keywords Tinnitus; clinical trials; combination device; feasibility; hearing aid; sound therapy
Public URL http://eprints.nottingham.ac.uk/id/eprint/40194
Publisher URL http://www.tandfonline.com/doi/full/10.1080/14992027.2016.1254822
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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