Evaluation of N6 Sound Processor in Group of Freedom Users

August 4, 2016 updated by: Cochlear
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults and children 12 years of age and older.

Description

Inclusion Criteria:

  • Subjects with sensorineural hearing loss
  • 12 years of age and older
  • Currently using Freedom Sound Processor
  • Recipient of a Ci22M or CI24 series implant
  • Minimum of 3 months experience with Freedom Sound Processor
  • Prior documentation of sentence recognition in noise at a +10 SNR or better
  • Native English speaker
  • Willingness to participate and comply with requirements of protocol

Exclusion Criteria:

  • Unable to complete test metrics
  • Unrealistic expectations regarding possible benefits
  • Additional handicaps that would prevent or restrict participation in audiological evaluations
  • ABI cochlear implant recipient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of N6 Sound Processor in Group of Freedom Users
Time Frame: 3 months of use
Speech recognition measures in quiet & noise via word and sentence rest and SSiQ questionnaire to compare freedom to upgrade with N6 relative to speech, spatial and quality dimensions and N6 questionnaire.
3 months of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Lori O'Neil, Au.D, Cochlear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM5623-FRN6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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