Single Sided Deafness
Conditions
Keywords
Single Sided Deafness, SSD, Unilateral hearing loss
Brief summary
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
Interventions
DEVICESoundBite
Non-surgical removable bone conduction device via the teeth.
Sponsors
Sonitus Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device * Must be \>18, \<80 years old * Must be fluent in English, as determined by the PI * Must have diagnosis of SSD, time since onset (≥3 months) * Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite * Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
Exclusion criteria
* Subjects with known hypersensitivity to any of the components including allergies to polymers. * Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling. * Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| APHAB Questionnaire | 30 days | Comparison of the SoundBite™ System and surgically implanted bone conduction devices |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Sided Deafness Questionnaire | 30 days | Comparison of the SoundBite™ System and surgically implanted BCD systems. |
Countries
United States
Contacts
Primary ContactLinda Galow, M.S.
Outcome results
None listed