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

NCT ID: NCT02934373

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A New Sound Processor

Sound Processor is the next generation sound processor.

Group Type ACTIVE_COMPARATOR

A New Sound Processor

Intervention Type DEVICE

Subject's own sound processor

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A New Sound Processor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 12 months old or older
2. Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
3. Use of the CP810, CP920 or CP910 sound processor
4. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria

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

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Beth Brinson

Role: STUDY_CHAIR

Head of Clinical Affairs

Locations

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SINT-Augustinus Antwerpen

Antwerp, Wilrijk, Belgium

Site Status

University of Southampton - Auditory Implant Service Highfield

Southampton, Hampshire, United Kingdom

Site Status

Nottingham University Hospitals - Queens Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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Belgium United Kingdom

Other Identifiers

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CLTD5665

Identifier Type: -

Identifier Source: org_study_id