Retrospective Analysis of Speech Performance Using the Hi... | NCT06301581

Studies
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant

NCT06301581

Sponsor

Advanced Bionics AG

Status

Unknown status

Last Update Posted

Mar 8, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Cochlear Hearing Loss

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 4, 2024

First Submission Date that Met QC Criteria

Mar 4, 2024

First Posted Date

Mar 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2024

Last Update Posted Date

Mar 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		HiRes Ultra or HiRes Ultra 3D Version V2 newly implanted on this side
Group 2		HiRes Ultra or HiRes Ultra 3D Version V2 implanted following an Ultra Version V1 device failure on the same ear

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freiburger monosyllabic word recognition score in quiet in the implanted ear	Score obtained with the Freiburger Monosyllabic word test	12 months after device activation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including
- Ultra Version V2 newly implanted on this side (Group 1)
- Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2)
Informed consent signed

Exclusion Criteria:

no exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The studied population consists of all CI users implanted with a HiRes Ultra Version V2 or HiRes Ultra 3D Version V2 CI at the Medical University of Hannover in Germany (MHH).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Büchner, Prof	Contact	49 511 532 8589		buechner.andreas@mh-hannover.de
Kliesch Sven	Contact	49 511 532 8069		Kliesch.Sven@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Andreas Büchner	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Hochschule Hannover	Recruiting	Hanover		D-30625	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006319	Hearing Loss, Sensorineural

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided