Trial Outcomes & Findings for Hearing Loss in Older Adults Study (NCT NCT03382769)

NCT ID: NCT03382769

Last Updated: 2022-12-22

Results Overview

The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 6 months after enrollment
• Results posted on: 2022-12-22

Participant Flow

Participant milestones

Measure	Group A (Immediate Cochlear Implantation) Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant	Group B (Delayed Cochlear Implantation) Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group A (Immediate Cochlear Implantation) Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant	Group B (Delayed Cochlear Implantation) n=1 Participants Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Sex: Female, Male Female	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Sex: Female, Male Male	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants

PRIMARY outcome

Timeframe: 6 months after enrollment

Population: Data was not collected as the study was terminated due to COVID-19

The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.

Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.

Outcome measures

Outcome data not reported

Adverse Events

Group A (Immediate Cochlear Implantation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B (Delayed Cochlear Implantation)

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

PRS Specialist, Clinical Affairs

Cochlear Limited

Phone: +612 9428 6555

Email: cltd-prs-admin@cochlear.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place