Trial Outcomes & Findings for ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users (NCT NCT01066780)

Results Overview

This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

4 Weeks

Results posted on

2020-07-22

Participant Flow

All subjects were fit acutely at the Baseline Visit (Visit 1) with ClearVoice Low and underwent acute speech perception testing. Each subject was then randomized to Group A or Group B.

Participant milestones

Participant milestones
Measure	Group A: Received ClearVoice MEDIUM Followed by HIGH Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.	Group B: Received ClearVoice HIGH Followed by MEDIUM Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
Overall Study STARTED	24	24
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: Received ClearVoice MEDIUM Followed by HIGH Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.	Group B: Received ClearVoice HIGH Followed by MEDIUM Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
Overall Study Withdrawn prior to ClearVoice exposure.	1	1

Baseline Characteristics

ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ClearVoice n=46 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 16.00 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.

Outcome measures

Outcome measures
Measure	Group 1 n=46 Participants Primary efficacy analyses were based on data from the 46 subjects that completed the study.
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise ClearVoice Setting Medium	8.7 percentage of words scored correctly Standard Deviation 10.10
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise ClearVoice Setting High	10.6 percentage of words scored correctly Standard Deviation 10.20

SECONDARY outcome

Timeframe: 2-4 weeks

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth Ripley, Director of Clinical Research

Advanced Bionics, LLC

Phone: 1.661.362.1400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At least 60 days before submission for publication, presentation or use, Institution or Principal Investigator will submit to Sponsor for review and comment any proposed oral or written Publication. Sponsor will have the right to request any modification of any Publication if in Sponsor's reasonable opinion that Publication would jeopardize a patent application or patent.
Publication restrictions are in place

Restriction type: OTHER