NCT03236909

Expanded Indications in the Adult Cochlear Implant Population

Completed NA Results posted Last updated 24 June 2025

What this trial tests

NA trial testing MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System in Hearing Loss, Sensorineural in 44 participants. Completed in 27 March 2023.

Timeline

16 April 2018

Primary endpoint
27 March 2023

27 March 2023

Quick facts

Lead sponsor	Med-El Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	16 April 2018
Primary completion	27 March 2023
Estimated completion	27 March 2023
Sites	5 locations across Canada, United States

Drugs / interventions tested

• MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System

Conditions studied

• Hearing Loss, Sensorineural — all drugs for Hearing Loss, Sensorineural →

Sponsor

Med-El Corporation — full company profile →

Who can join

18 and older, any sex, with Hearing Loss, Sensorineural. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Percent Correct on Word Recognition in Quiet in Implanted Ear Primary · 6 months post-activation

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.

Group	Value	95% CI
Single-arm	25.6	± 22.8

Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear Primary · 6 months post-activation

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.

Group	Value	95% CI
Single-arm	24.1	± 25.3

Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition Secondary · 6 months post-activation

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).

Group	Value	95% CI
Single-arm	-29.5	± 19.2

Number of Participants Experiencing an Adverse Device Effect (ADE) Secondary · 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.

Group	Value	95% CI
Single-arm	31

Number of Participants With Residual Low-frequency Hearing Secondary · 6 months post-activation

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.

Group	Value	95% CI
Single-arm	3
Single-arm	24
Single-arm	4
Single-arm	12

Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition Secondary · 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.

Group	Value	95% CI
Single-arm	1.9	± 1.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-arm

Serious: 21/44 (48%)

Deaths: 0/44

Serious adverse events (2 terms)

Reaction	System	Single-arm
Loss of residual hearing	Ear and labyrinth disorders	—
Vertigo	Ear and labyrinth disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Single-arm
Temporary loss of residual hearing	Ear and labyrinth disorders	—
Dizziness, imbalance, vertigo	Ear and labyrinth disorders	—

Most-reported serious reactions: Loss of residual hearing, Vertigo.

Data from ClinicalTrials.gov NCT03236909 adverse events section.

Sponsor's own description

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.