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 ad...
| Publicado en: | International Journal of Audiology Vol. 56; no. 4; pp. 286 - 295 |
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| Autores principales: | , , |
| Formato: | questionnaire/scale research tables/charts Journal Article |
| Publicado: |
Taylor & Francis Ltd
Apr2017
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| Acceso en línea: | Ver este registro en EBSCOhost |
| Sumario: | 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. |
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