Evaluation of Subjective Ratings on a New Sound Processor... | NCT02934373

Studies
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products

NCT02934373

Sponsor

Cochlear

Status

Withdrawn

Last Update Posted

Nov 17, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

A New Sound Processor

Countries

Belgium
United Kingdom

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Nov 2016Actual

Completion Date

Not provided

First Submitted Date

Oct 13, 2016

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 17, 2016Estimated

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

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A New Sound Processor	Active Comparator	Sound Processor is the next generation sound processor.	Device: A New Sound Processor
Subject's own sound processor	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A New Sound Processor	Device		A New Sound Processor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective rating with a new sound processor compared to ratings with each subjects own processor		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12 months old or older
Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
Use of the CP810, CP920 or CP910 sound processor
Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
Additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Beth Brinson	Head of Clinical Affairs	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SINT-Augustinus Antwerpen		Antwerp	Wilrijk	2610	Belgium
University of Southampton - Auditory Implant Service Highfield

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided