Hearing Loss, Sensorineural
Conditions
Brief summary
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.
Detailed description
Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. . Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.
Interventions
DEVICEMED-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.
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, 18 years of age or older at the time of implantation * Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz) * Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB * Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear * CNC word score in quiet of greater than or equal to 10% in the ear to be implanted * Evidence of appropriately fit hearing aids as determined by the audiologist * Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal * Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification * If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study * Fluent in English * No radiological contraindications * Ability to undergo general anesthesia * Appropriate motivation and expectation levels * Stated willingness to comply with all study procedures for the duration of the study
Exclusion criteria
* Evidence that hearing loss is retrocochlear in origin * Active middle ear infection * Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction * History of prior use of a hearing implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Correct on Word Recognition in Quiet in Implanted Ear | 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. |
| Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition | 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). |
| Number of Participants Experiencing an Adverse Device Effect (ADE) | 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. |
| Number of Participants With Residual Low-frequency Hearing | 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. |
| Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single-arm 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. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Single-arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 29 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 68.1 years STANDARD_DEVIATION 15.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment Canada | 12 participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 10 / 44 |
| serious Total, serious adverse events | 21 / 44 |
Outcome results
Primary
Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear | 24.1 Change in percentage points | Standard Deviation 25.3 |
Primary
Change in Percent Correct on Word Recognition in Quiet in Implanted Ear
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Change in Percent Correct on Word Recognition in Quiet in Implanted Ear | 25.6 Change in percentage points | Standard Deviation 22.8 |
Secondary
Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition | -29.5 Change in percent, listening difficulty | Standard Deviation 19.2 |
Secondary
Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm | Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition | 1.9 Units on a scale | Standard Deviation 1.9 |
Secondary
Number of Participants Experiencing an Adverse Device Effect (ADE)
Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE.
Time frame: Through study completion, or at least 1 year, 4 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-arm | Number of Participants Experiencing an Adverse Device Effect (ADE) | 31 Participants |
Secondary
Number of Participants With Residual Low-frequency Hearing
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single-arm | Number of Participants With Residual Low-frequency Hearing | Minimal Hearing Preservation (<25%) | 4 Participants |
| Single-arm | Number of Participants With Residual Low-frequency Hearing | No Hearing Preservation | 12 Participants |
| Single-arm | Number of Participants With Residual Low-frequency Hearing | Complete Hearing Preservation (>75%) | 3 Participants |
| Single-arm | Number of Participants With Residual Low-frequency Hearing | Partial Hearing Preservation (25-75%) | 24 Participants |