Acceptance of the CP950 Sound Processor

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: CP950 OTE Sound processor

• Registration Number: NCT03613909
• Lead Sponsor: Cochlear

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-31
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Results First Submitted: 2019-02-04
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Results First Posted: 2023-09-28
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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. Native 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	CP950 OTE Sound processor	At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor.

Primary Outcome Measures

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

Name	Time	Method
Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor	In booth testing 1 day	Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome.
Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .	in booth testing 1 day.	Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor.