Acceptance of the CP950 Sound Processor

NCT03613909 | Completed Results

• 1 other identifier: CLTD5591
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

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

  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.

  14 days

Secondary Outcomes (2)

• Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .

  in booth testing 1 day.

• Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor

  In booth testing 1 day

Study Arms (1)

All participants

EXPERIMENTAL

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.

Device: CP950 OTE Sound processor

Interventions

CP950 OTE Sound processor DEVICE

CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marian Jones, Principal Investigator
• Organization: Cochlear Ltd

mjones@cochlear.com

+61498008181

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Repeated measures, single-subject experiment. Each subject received the same treatment.

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: August 3, 2018
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share