Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459765
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-03
Brief Title:
Mi2000 Totally Implantable Cochlear Implant Mi2000 TICI
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
MED-EL Elektromedizinische Geräte GesmbH
Study Overview
Official Title:
Mi2000 Totally Implantable Cochlear Implant Mi2000 TICI Pivotal Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant The main question it aims to answer is whether the device is able to improve speech perception compared to the pre-operative score
Participants will undergo cochlear implantation and fitting and will be asked to perform the following tests pre- and post-operatively
Word test in quiet
Sentence test in noise
Audiograms
Health Utilities Index 2 and 3 HUI23 a generic quality-of-life questionnaire
Nijmengen Cochlear Implant Questionnaire NCIQ a disease specific quality-of life questionnaire
Speech Spatial and Qualities of Hearing Scale SSQ12 a disease specific questionnaire
Hearing Implant Sound Quality Index HISQUI19 a sound quality questionnaire
Participants will undergo cochlear implantation and fitting and will be asked to perform the following tests pre- and post-operatively
Word test in quiet
Sentence test in noise
Audiograms
Health Utilities Index 2 and 3 HUI23 a generic quality-of-life questionnaire
Nijmengen Cochlear Implant Questionnaire NCIQ a disease specific quality-of life questionnaire
Speech Spatial and Qualities of Hearing Scale SSQ12 a disease specific questionnaire
Hearing Implant Sound Quality Index HISQUI19 a sound quality questionnaire
Detailed Description:
Cochlear implants CI provide a large majority of recipients with a significant degree of speech understanding However CI systems rely on external audio processors to function This can have several disadvantages for instance the hardware is exposed to external trauma and to the effects of head movement and gravity The device is also put at risk by humid dusty or dirty conditions as well as by physical activities that lead to water exposure such as swimming or sports in general eg perspiration
In addition some patients are concerned with the cosmetic appearance of the external parts which are visible more so than modern behind-the-ear hearing aids something that may not be desirable to many potential candidates
This clinical investigation aims to collect confirmatory data on the use of the Mi2000 Totally Implantable Cochlear Implant system used in combination with compatible devices
In addition some patients are concerned with the cosmetic appearance of the external parts which are visible more so than modern behind-the-ear hearing aids something that may not be desirable to many potential candidates
This clinical investigation aims to collect confirmatory data on the use of the Mi2000 Totally Implantable Cochlear Implant system used in combination with compatible devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None