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Clinical Trials/NCT03613909
NCT03613909
Completed
Not Applicable

Acceptance of the CP950 Sound Processor With Experienced CP810/CP910/CP920 BTE Sound Processor Users

Cochlear0 sites23 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss, Sensorineural
Sponsor
Cochlear
Enrollment
23
Primary Endpoint
Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
November 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Cochlear
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Eighteen years of age or older
  • At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
  • At least 3 months experience with the CP810,CP920 or CP910 sound processor
  • Native speaker in the language used to assess speech perception performance
  • Willingness to participate in and to comply with all requirements of the protocol
  • Able to score 30% or more at +15 SNR with CI alone

Exclusion Criteria

  • 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 that would prevent participation in evaluations
  • Nucleus 22 Implant

Outcomes

Primary Outcomes

Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.

Time Frame: 14 days

Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better.

Secondary Outcomes

  • Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor(In booth testing 1 day)
  • Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .(in booth testing 1 day.)

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