Trial Outcomes & Findings for Electric-Acoustic Stimulation Extended Follow-up Post Approval Study (NCT NCT03031678)

Results Overview

Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Study Procedures Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
Overall Study STARTED	50
Overall Study EAS Test Condition Complete	39
Overall Study CI Alone Test Condition Complete	10
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Procedures Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
Overall Study Study closed prior to completion	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Procedures n=50 Participants Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
Age, Categorical <=18 years	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=50 Participants
Age, Categorical >=65 years	11 Participants n=50 Participants
Age, Continuous	55.58 years STANDARD_DEVIATION 13.24 • n=50 Participants
Sex: Female, Male Female	27 Participants n=50 Participants
Sex: Female, Male Male	23 Participants n=50 Participants
Region of Enrollment United States	50 participants n=50 Participants
Ear Implanted Right	27 Participants n=50 Participants
Ear Implanted Left	23 Participants n=50 Participants

PRIMARY outcome

Timeframe: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.

Outcome measures

Outcome measures
Measure	Electric Acoustic Stimulation n=39 Participants Subjects tested with a combination of electric and acoustic stimulation	CI Alone n=10 Participants Subjects testing with electric stimulation only
Percentage of Words Correct As Assessed by CUNY Sentence Test.	61.33 percentage of words correct Standard Deviation 27.05	43.30 percentage of words correct Standard Deviation 33.10

SECONDARY outcome

Timeframe: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.

Outcome measures

Outcome measures
Measure	Electric Acoustic Stimulation n=50 Participants Subjects tested with a combination of electric and acoustic stimulation	CI Alone Subjects testing with electric stimulation only
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. Complete Hearing Preservation	6 Participants	—
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. Partial Hearing Preservation	31 Participants	—
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. Minimal Hearing Perservation	9 Participants	—
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. No Hearing Preservation	4 Participants	—

SECONDARY outcome

Timeframe: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.

Outcome measures

Outcome measures
Measure	Electric Acoustic Stimulation n=39 Participants Subjects tested with a combination of electric and acoustic stimulation	CI Alone n=10 Participants Subjects testing with electric stimulation only
Percentage of Words Correct as Assessed by CNC Words in Quiet.	73.59 percentage of words correct Standard Deviation 13.71	57.40 percentage of words correct Standard Deviation 23.29

SECONDARY outcome

Timeframe: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Population: 46 completed the questionnaire

The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.

Outcome measures

Outcome measures
Measure	Electric Acoustic Stimulation n=46 Participants Subjects tested with a combination of electric and acoustic stimulation	CI Alone Subjects testing with electric stimulation only
Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.	35.39 percentage of listening difficulty Standard Deviation 13.89	—

Adverse Events

Study Procedures

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Procedures n=50 participants at risk Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid
Ear and labyrinth disorders Loss of Residual Hearing	14.0% 7/50 • Number of events 7 • 3 Years (Duration of the Study) Any adverse event reported by a subject over the duration of the study is included here. Subjects were monitored through at least five years post-implantation from the original clinical trial.
Ear and labyrinth disorders Internal Device Failure	2.0% 1/50 • Number of events 1 • 3 Years (Duration of the Study) Any adverse event reported by a subject over the duration of the study is included here. Subjects were monitored through at least five years post-implantation from the original clinical trial.

Other adverse events

Adverse event data not reported

Additional Information

Allison Racey

MED-EL Corporation

Phone: 1-888-633-3524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place