Trial Outcomes & Findings for Expanded Indications in the Adult Cochlear Implant Population (NCT NCT03236909)

Last Updated: 2025-06-24

Results Overview

CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

6 months post-activation

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Single-arm Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Overall Study STARTED	44
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Expanded Indications in the Adult Cochlear Implant Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm n=44 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY 2 (PIN) Cochlear Implant System: Subjects were implanted with the MED-EL SYNCHRONY/SYNCHRONY 2 (PIN) Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects were fit with the SONNET/SONNET 2 EAS (ear-level) and/or RONDO/RONDO 2/RONDO 3 (single-unit) external audio processors.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age, Continuous	68.1 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-activation

Population: Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for primary endpoint analysis.

Outcome measures

Outcome measures
Measure	Single-arm n=43 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Change in Percent Correct on Word Recognition in Quiet in Implanted Ear	25.6 Change in percentage points Standard Deviation 22.8

PRIMARY outcome

Timeframe: 6 months post-activation

Population: Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for primary endpoint analysis.

AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

Outcome measures

Outcome measures
Measure	Single-arm n=43 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear	24.1 Change in percentage points Standard Deviation 25.3

SECONDARY outcome

Timeframe: 6 months post-activation

Population: Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for endpoint analysis. Note: not all participants completed the patient questionnaire.

APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) questionnaire will be used to assess subjective outcomes and reported as change in mean Global Score at 6 months post-activation compared to baseline. Letter responses from A to G on each question have a percent value, and the Global Score is an average percent value of all letters. A lower score shows less difficulty (better performance).

Outcome measures

Outcome measures
Measure	Single-arm n=41 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition	-29.5 Change in percent, listening difficulty Standard Deviation 19.2

SECONDARY outcome

Timeframe: Through study completion, or at least 1 year, 4 months post-implantation

Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE.

Outcome measures

Outcome measures
Measure	Single-arm n=44 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Number of Participants Experiencing an Adverse Device Effect (ADE)	31 Participants

SECONDARY outcome

Timeframe: 6 months post-activation

Population: Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for endpoint analysis.

HEARRING scale will be used to calculate the percent of hearing preservation for each subject by comparing average hearing thresholds from 125 to 1000 Hz at 6 months post-activation to the average at baseline.

Outcome measures

Outcome measures
Measure	Single-arm n=43 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Number of Participants With Residual Low-frequency Hearing Complete Hearing Preservation (>75%)	3 Participants
Number of Participants With Residual Low-frequency Hearing Partial Hearing Preservation (25-75%)	24 Participants
Number of Participants With Residual Low-frequency Hearing Minimal Hearing Preservation (<25%)	4 Participants
Number of Participants With Residual Low-frequency Hearing No Hearing Preservation	12 Participants

SECONDARY outcome

Timeframe: 6 months post-activation

The SSQ (Spatial and Qualities of Hearing) questionnaire will be used to assess subjective outcomes and reported as change in mean Overall Score at 6 months post-activation compared to baseline. SSQ is scored on a 10-point Likert scale where 10 shows better listening skills/experiences than 0.

Outcome measures

Outcome measures
Measure	Single-arm n=41 Participants Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition	1.9 Units on a scale Standard Deviation 1.9

Adverse Events

Single-arm

Serious events: 21 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single-arm n=44 participants at risk Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Ear and labyrinth disorders Loss of residual hearing	47.7% 21/44 • Number of events 21 • Adverse device effects were collected through study completion for all participants. Timeframe for adverse event reporting ranged from 1 year, 4 months for the last implanted subject to 4 years, 10 months for the first implanted subject.
Ear and labyrinth disorders Vertigo	2.3% 1/44 • Number of events 1 • Adverse device effects were collected through study completion for all participants. Timeframe for adverse event reporting ranged from 1 year, 4 months for the last implanted subject to 4 years, 10 months for the first implanted subject.

Other adverse events

Other adverse events
Measure	Single-arm n=44 participants at risk Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Ear and labyrinth disorders Temporary loss of residual hearing	15.9% 7/44 • Number of events 7 • Adverse device effects were collected through study completion for all participants. Timeframe for adverse event reporting ranged from 1 year, 4 months for the last implanted subject to 4 years, 10 months for the first implanted subject.
Ear and labyrinth disorders Dizziness, imbalance, vertigo	6.8% 3/44 • Number of events 3 • Adverse device effects were collected through study completion for all participants. Timeframe for adverse event reporting ranged from 1 year, 4 months for the last implanted subject to 4 years, 10 months for the first implanted subject.

Additional Information

Clinical Research Manager

MED-EL Corporation

Phone: 888-633-3524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60