Acceptance of the CP950 Sound Processor

N/ACompletedNCT03613909

Cochlear23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

CP950 OTE Sound processorDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 14 days

Secondary Outcomes

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.

Time frame: in booth testing 1 day.

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.

Time frame: In booth testing 1 day

Data from ClinicalTrials.gov

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