Acceptance of the CP950 Sound Processor | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP950 OTE Sound processor

Device

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

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

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

Time frame: 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.
Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 3, 2018
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed