Hearing Loss, Sensorineural
Conditions
Brief summary
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
Detailed description
This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.
Interventions
DEVICEAudio processor
MED-EL SONNET 3 (EAS) audio processor
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Implanted with a MED-EL cochlear implant in at least one ear * ≥ 12 months since activation of the MED-EL audio processor * Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor * Ability to complete all study procedures * Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study
Exclusion criteria
* Evidence that hearing loss is retrocochlear in origin * Unable to provide reliable feedback during cochlear implant programming * Skin or scalp condition precluding use of the study device * Unrealistic participant or parent (if applicable) motivation or expectations * Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Reporting Improvement With SONNET 3 Design | Measured 1 month after baseline | The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Audiologist Satisfaction Ratings | Measured after study completion, an average of 7.5 months | Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SONNET 3 (EAS) Participants complete a take-home trial using SONNET 3 (EAS) audio processor | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | SONNET 3 (EAS) |
|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 24.1 |
| Cochlear Implant Experience | 6.1 years STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Participants Reporting Improvement With SONNET 3 Design
The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey
Time frame: Measured 1 month after baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SONNET 3 (EAS) | Participants Reporting Improvement With SONNET 3 Design | 20 Participants |
Secondary
Audiologist Satisfaction Ratings
Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey.
Time frame: Measured after study completion, an average of 7.5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SONNET 3 (EAS) | Audiologist Satisfaction Ratings | SONNET 3 Design | 5.4 Score on 6-point Likert scale | Standard Deviation 0.3 |
| SONNET 3 (EAS) | Audiologist Satisfaction Ratings | MAESTRO 11 | 5.5 Score on 6-point Likert scale | Standard Deviation 0.5 |