Trial Outcomes & Findings for Retrospective CI532 Hearing Performance (NCT NCT03039283)

Results Overview

Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.

Recruitment status

COMPLETED

Target enrollment

162 participants

Primary outcome timeframe

pre-operatively and at 6 months post-operatively

Results posted on

2019-10-30

Participant Flow

162 participants were recruited in five German centres from March 2017 to August 2018

Participant milestones

Participant milestones
Measure	Nucleus CI532 Cochlear Implant Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Overall Study STARTED	162
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Nucleus CI532 Cochlear Implant Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Overall Study Protocol Violation	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nucleus CI532 Cochlear Implant n=159 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Age, Continuous	56.6 years STANDARD_DEVIATION 18 • n=159 Participants
Sex: Female, Male Female	73 Participants n=159 Participants
Sex: Female, Male Male	86 Participants n=159 Participants
Region of Enrollment Germany	159 Participants n=159 Participants

PRIMARY outcome

Timeframe: pre-operatively and at 6 months post-operatively

Population: 49 participants with routine speech understanding data available at pre-op and 6 months were analysed.

Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.

Outcome measures

Outcome measures
Measure	Nucleus CI532 Cochlear Implant n=49 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).	26.1 Percent correct Standard Deviation 26.7

PRIMARY outcome

Timeframe: pre-operatively and at 6 months post-operatively

Population: 15 participants with routine speech understanding data in noise available at pre-op and at 6 months were analyzed.

Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. An adaptive procedure is used such that after each sentence is presented the speech level is decreased if \>50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.

Outcome measures

Outcome measures
Measure	Nucleus CI532 Cochlear Implant n=15 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions).	-5.5 Speech Recognition Threshold in decibels Standard Deviation 11.2

PRIMARY outcome

Timeframe: pre-operatively and at 6 months post-operatively

Population: 99 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare.

Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.

Outcome measures

Outcome measures
Measure	Nucleus CI532 Cochlear Implant n=99 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet.	96 Percentage of participants Interval 90.0 to 98.9

PRIMARY outcome

Timeframe: Pre-operatively and at 6 months post-operatively

Population: 60 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare.

Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.

Outcome measures

Outcome measures
Measure	Nucleus CI532 Cochlear Implant n=60 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet	73.3 Percentage of participants Interval 60.0 to 84.0

PRIMARY outcome

Timeframe: Pre-operatively and at 6 months post-operatively

Population: 36 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare.

Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if \>50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.

Outcome measures

Outcome measures
Measure	Nucleus CI532 Cochlear Implant n=36 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise.	67 Percentage of participants Interval 49.0 to 81.0

PRIMARY outcome

Timeframe: Pre-operatively and at 6 months post-operatively

Population: 4 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare.

Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if \>50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.

Outcome measures

Outcome measures
Measure	Nucleus CI532 Cochlear Implant n=4 Participants Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise.	75 Percentage of participants Interval 19.0 to 99.0

Adverse Events

Nucleus CI532 Cochlear Implant

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

Nicole Neben

Cochlear

Phone: +4951154277220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators will be able to publish and/or present their own data. The publishing investigator will provide the sponsor with a manuscript copy of the abstract and paper at least 30 days in advance of publication or presentation. If the publication contains information that the sponsor at his discretion finds worth protecting in the form of a patent or trademark etc., the sponsor has the right to delay the publication or presentation for 90 days.
Publication restrictions are in place

Restriction type: OTHER