MAGDALENA SEREDA Magdalena.Sereda@nottingham.ac.uk
Assistant Professor
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
Deborah A. Hall
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 and Francis |
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 | https://nottingham-repository.worktribe.com/output/826971 |
Publisher URL | http://www.tandfonline.com/doi/full/10.1080/14992027.2016.1254822 |
Contract Date | Feb 1, 2017 |
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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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