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NCT02934373 Clinical Trial

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

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02934373
Other study ID # CLTD5665
Secondary ID
Status Withdrawn
Phase N/A
First received October 13, 2016
Last updated November 15, 2016

Study information
Verified date November 2016
Source Cochlear
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 100 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• A New Sound Processor

Locations
Country Name City State
Belgium SINT-Augustinus Antwerpen Antwerp Wilrijk
United Kingdom Nottingham University Hospitals - Queens Medical Centre Nottingham Nottinghamshire
United Kingdom University of Southampton - Auditory Implant Service Highfield Southampton Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Cochlear

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective rating with a new sound processor compared to ratings with each subjects own processor 3 months No
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