Hearing Loss, Sensorineural
Conditions
Brief 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.
Detailed description
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.
Interventions
DEVICEElectric-Acoustic Stimulation (EAS) Cochlear Implant System
Combination of a cochlear implant and a hearing aid
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Words Correct As Assessed by CUNY Sentence Test. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. | 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. |
| Percentage of Words Correct as Assessed by CNC Words in Quiet. | 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. |
| Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire. | Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Procedures Electric-Acoustic Stimulation (EAS) Cochlear Implant System: Combination of a cochlear implant and a hearing aid | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study closed prior to completion | 1 |
Baseline characteristics
| Characteristic | Study Procedures | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 11 Participants | — |
| Age, Categorical Between 18 and 65 years | 39 Participants | — |
| Age, Continuous | 55.58 years STANDARD_DEVIATION 13.24 | — |
| Ear Implanted Left | 23 Participants | — |
| Ear Implanted Right | 27 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 participants | — |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 8 / 50 |
Outcome results
Primary
Percentage of Words Correct As Assessed by CUNY Sentence Test.
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.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electric Acoustic Stimulation | Percentage of Words Correct As Assessed by CUNY Sentence Test. | 61.33 percentage of words correct | Standard Deviation 27.05 |
| CI Alone | Percentage of Words Correct As Assessed by CUNY Sentence Test. | 43.30 percentage of words correct | Standard Deviation 33.1 |
Secondary
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
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.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Electric Acoustic Stimulation | Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. | Complete Hearing Preservation | 6 Participants |
| Electric Acoustic Stimulation | Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. | Minimal Hearing Perservation | 9 Participants |
| Electric Acoustic Stimulation | Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. | No Hearing Preservation | 4 Participants |
| Electric Acoustic Stimulation | Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. | Partial Hearing Preservation | 31 Participants |
Secondary
Percentage of Words Correct as Assessed by CNC Words in Quiet.
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.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electric Acoustic Stimulation | Percentage of Words Correct as Assessed by CNC Words in Quiet. | 73.59 percentage of words correct | Standard Deviation 13.71 |
| CI Alone | Percentage of Words Correct as Assessed by CNC Words in Quiet. | 57.40 percentage of words correct | Standard Deviation 23.29 |
Secondary
Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) 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.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Population: 46 completed the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electric Acoustic Stimulation | 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 |