Efficacy of a combination hearing aid and sound generator

Completed

• Conditions: Tinnitus; Ear, Nose and Throat

• Registration Number: ISRCTN15178771
• Lead Sponsor: Oticon A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-27
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Hearing impaired with flat or mild to moderate-severe sloping sensorineural hearing loss (SNHL). Hearing loss can be asymmetrical provided participant has been medically cleared for red flag conditions by a physician or otolaryngologist.
2. No limitation on type of fitting that can be worn (e.g. open fitting, closed dome, ear mold allowed, depending on HL).
3. New hearing instrument users preferred to eliminate pre-user bias.
4. GAD-7 anxiety screening: score from 0-9, indicating no anxiety or minimal to mild anxiety only.
5. PHQ-9 depression screening: score from 0-9, indicating no depression or minimal to mild depression only.
6. TFI questionnaire: tinnitus symptoms ranging in severity rating from =32 to =71 points.
7. Age 18 and over
8. Only mild hyperacusis symptoms

Exclusion Criteria

1. Clinical diagnosis of moderate to severe depression (score =10 in PHQ-9 screening)
2. Clinical diagnosis of moderate to severe anxiety disorder (score =10 in GAD-7 screening)
3. Patients with severe to profound hearing loss
4. Normal hearing tinnitus patients
5. Patients with very mild or severe to profound tinnitus symptoms
6. Patient where main symptom is hyperacusis
7. Patient cannot hear the sound generator signal at 82 dB(A)SP

Study & Design

• Study Type: Interventional
• Study Design: Not specified