Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641999
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults with Chronic Tinnitus and Varying Levels of Hearing Loss
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicentric Feasibility Investigation to Assess the Effect of the Tinnitus Implant on Tinnitus Loudness in Adults with Moderate to Severe Chronic Tinnitus Accompanied by Normal Hearing to Moderately Severe Hearing Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TINIS
Brief Summary:
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant sound processor and programming software The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve The sound processor is worn behind the ear and powers the implant via the coil The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance and self-reported questionnaires on their tinnitus and general health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None