Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642935
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant TICI Research System in Adults with Severe Hearing Loss
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Feasibility Interventional Prospective Study to Enhance Features and Optimise the Clinical Pathway for the TICI Research System in Adult Cochlear Implant Recipients
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:
ENHANCE
Brief Summary:
This clinical study will test a new investigational totally implanted cochlear implant system TICI G2 The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts This study will explore new ways to process the sound from the implanted microphone The study will be conducted in adults with sensorineural hearing loss a type of hearing loss caused by damage to the inner ear or auditory nerve The study participants will undergo a series of tests that include testing their implant and their hearing They will also complete questionnaires to see how they rate their hearing and overall 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