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.

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: https://nottingham-repository.worktribe.com/output/826971
• Publisher URL: http://www.tandfonline.com/doi/full/10.1080/14992027.2016.1254822