Acceptance of the CP950 Sound Processor

Hearing Loss, Sensorineural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613909
• Other study ID #: CLTD5591
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2023
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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. 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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• CP950 OTE Sound processor
CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .	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.	in booth testing 1 day.
Secondary	Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor	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.	In booth testing 1 day