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

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.