Clinical Evaluation of a Cochlear Implant System

Sensorineural Hearing Loss Clinical Trial

Official title:

Clinical Evaluation of a Cochlear Implant System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467399
• Other study ID #: CLTD5620
• Status: Completed
• Phase: N/A
• First received: September 16, 2016
• Last updated: March 9, 2018
• Start date: July 1, 2016
• Est. completion date: September 7, 2017

Study information

• Verified date: March 2018
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the usability of a Cochlear implant system.

Description:

Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 7, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Eighteen years of age or older

2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear

3. At least 3 months experience with the CP810,CP920 or CP910 sound processor

4. Fluent speaker in the language used to assess speech perception performance

5. Willingness to participate in and to comply with all requirements of the protocol

6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

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 that would prevent participation in evaluations

3. Nucleus 22 Implant

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• Nucleus 7 Cochlear Implant System
A new cochlear implant sound processor system.

Locations

Country	Name	City	State
Australia	Cochlear Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.	Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.	One year
Secondary	Speech perception performance of the CP1000 Sound Processor in quiet and in noise.	Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories.	One year