Trial Outcomes & Findings for Acceptance of the CP950 Sound Processor (NCT NCT03613909)

Last Updated: 2023-09-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

14 days

Results posted on

2023-09-28

Participant Flow

Protocol stated "up to 25" number of participants. 23 were enrolled, with 3 electing to withdraw from the study before completion.

Participant milestones

Participant milestones
Measure	All Participants 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.
First Take Home Use of CP950 STARTED	23
First Take Home Use of CP950 COMPLETED	20
First Take Home Use of CP950 NOT COMPLETED	3
First In Booth Testing of CP950 STARTED	20
First In Booth Testing of CP950 COMPLETED	20
First In Booth Testing of CP950 NOT COMPLETED	0
Second Take Home Use of CP950 STARTED	20
Second Take Home Use of CP950 COMPLETED	20
Second Take Home Use of CP950 NOT COMPLETED	0
Second In Booth Testing of CP950 STARTED	20
Second In Booth Testing of CP950 COMPLETED	20
Second In Booth Testing of CP950 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=23 Participants All participants enrolled in the study
Age, Categorical <=18 years	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=23 Participants
Age, Categorical >=65 years	7 Participants n=23 Participants
Age, Continuous	57 years n=23 Participants
Sex: Female, Male Female	13 Participants n=23 Participants
Sex: Female, Male Male	10 Participants n=23 Participants
Region of Enrollment Australia	23 participants n=23 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants 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.
Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.	3.6 Units on a likert scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants 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.
Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .	4 decibles Standard Error 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants 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.
Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor	49.82 percentage of correct words. Standard Deviation 3.9

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=20 participants at risk 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.
Investigations Discomfort Headache and pain	45.0% 9/20 • Number of events 9 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
Ear and labyrinth disorders Tinnitus	10.0% 2/20 • Number of events 2 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
Ear and labyrinth disorders Loud Crackling sound	5.0% 1/20 • Number of events 1 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
General disorders Vertigo and pre planned hospitalization	15.0% 3/20 • Number of events 3 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
Infections and infestations Ear infection	5.0% 1/20 • Number of events 1 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
Social circumstances Fall at car park	5.0% 1/20 • Number of events 1 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
Investigations Pain at the site of processor magnet	5.0% 1/20 • Number of events 1 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).
Infections and infestations Pleurisy	5.0% 1/20 • Number of events 1 • 11 months Adverse events were collected during the periods when participants were using the investigational device (CP950).

Additional Information

Marian Jones, Principal Investigator

Cochlear Ltd

Phone: +61498008181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place