NCT02934373

Brief Summary

Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

First QC Date

October 13, 2016

Last Update Submit

November 15, 2016

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Subjective rating with a new sound processor compared to ratings with each subjects own processor

    3 months

Study Arms (2)

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

A New Sound ProcessorDEVICE
A New Sound Processor

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

SINT-Augustinus Antwerpen

Antwerp, Wilrijk, 2610, Belgium

Location

University of Southampton - Auditory Implant Service Highfield

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

Nottingham University Hospitals - Queens Medical Centre

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Beth Brinson

    Head of Clinical Affairs

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 17, 2016

Primary Completion

November 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)BE(1)