N/A N=50 Other

Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Hearing Loss, Sensorineural

Bottom Line

View on ClinicalTrials.gov: NCT03031678 ↗

Enrolled (actual)

Serious AEs

16.0%

Results posted

Sep 2020

Primary outcome: Primary: Percentage of Words Correct As Assessed by CUNY Sentence Test. — 61.33; 43.30 percentage of words correct

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Electric-Acoustic Stimulation (EAS) Cochlear Implant System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Med-El Corporation
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Words Correct As Assessed by CUNY Sentence Test.	61.33; 43.30	—
SECONDARY Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.	6; 31; 9; 4	—
SECONDARY Percentage of Words Correct as Assessed by CNC Words in Quiet.	73.59; 57.40	—
SECONDARY Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.	35.39	—

Summary

The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

Eligibility Criteria

Inclusion Criteria

18 years of age or older at the time of implantation
Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
CNC word recognition score less than or equal to 60% in the ear to be implanted
CNC word recognition score less than or equal to 60% in the contralateral ear
English spoken as the primary language

Exclusion Criteria

Conductive, retrocochlear, or central auditory disorder
Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
Developmental delays or organic brain dysfunction
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
Unwillingness or inability of the candidate to comply with all investigational requirements

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03031678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.