Conductive Hearing Loss, Mixed Hearing Loss, Single-Sided Deafness
Conditions
Brief summary
Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.
Interventions
DEVICESophono Bone Conduction Hearing Systems
The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of Bone Conduction (BC) of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea. The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear.
Sponsors
Medtronic Surgical Technologies
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Inclusion criteria
* Any subject who currently has or who has had the Sophono implant (including those who have been explanted) * Has or has had Sophono implant for 3 months or longer
Exclusion criteria
* Subject has implant but is unable or unwilling to perform audiologic testing * Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant | From Implantation to Study Visit, up to 6 years | The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam. |
| Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor | 1 day | The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor | 1 day | All participants were tested with both the Alpha 2 and Alpha 2 MPO processor and also with no processor (Air Conduction) and a standard lab vibration device (Bone Conduction). The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor compared to the PTA aided by Alpha 2 MPO processor. |
| Percentage of Participants Satisfied After System Use | 1 day | Subject satisfaction, via non-validated satisfaction questions |
| Assess QOL After System Use | 1 day | QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment. The APHAB is a questionnaire with four subscales (Ease of Communication, Reverberation, Background Noise, and Aversiveness). Items are answered on a seven-point scale from always to never. Scores for subscales can range from 0% (no difficulty) to 99% (maximum difficulty). Negative scores reflect a better benefit from aided hearing all subcategories are reported in percentiles. Abbreviated Profile of Hearing Aid Benefit was taken at 1 time point. Per request of site Institutional Review Board (IRB) pediatric patients were given a pediatric version. Calculation compared aided to unaided hearing. A global score is computed by averaging the East of Communication, Reverberation, and Background Noise scale scores. Questions are answered for unaided and aided listening. Aided scores are subtracted from unaided scores. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All Study Participants | 71 |
| All Participants All Study Participants | 74 |
| Total | 145 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 23.1 years |
| Region of Enrollment United States | 71 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 9 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor
The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry.
Time frame: 1 day
Population: 69 participants had prospective data (72 ears) and no data was obtained for 2 subjects (deviations noted) so the number of ears analyzed was 70 (67 subjects).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor | 79.1 decibles | Standard Deviation 21.4 |
| None BC | Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor | 41.2 decibles | Standard Deviation 26.8 |
| Aided Alpha 2 | Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor | 39.4 decibles | Standard Deviation 11.2 |
| Aided Alpha 2 MPO | Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor | 35.7 decibles | Standard Deviation 11 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant
The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam.
Time frame: From Implantation to Study Visit, up to 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant | 0.038 Proportion of Adverse Events |
Secondary
Assess QOL After System Use
QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment. The APHAB is a questionnaire with four subscales (Ease of Communication, Reverberation, Background Noise, and Aversiveness). Items are answered on a seven-point scale from always to never. Scores for subscales can range from 0% (no difficulty) to 99% (maximum difficulty). Negative scores reflect a better benefit from aided hearing all subcategories are reported in percentiles. Abbreviated Profile of Hearing Aid Benefit was taken at 1 time point. Per request of site Institutional Review Board (IRB) pediatric patients were given a pediatric version. Calculation compared aided to unaided hearing. A global score is computed by averaging the East of Communication, Reverberation, and Background Noise scale scores. Questions are answered for unaided and aided listening. Aided scores are subtracted from unaided scores.
Time frame: 1 day
Population: In this study 63 of 71 subjects completed the APHAB.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Assess QOL After System Use | Aversiveness (%) | 44.3 Percentage of Score (hearing problem) | Standard Deviation 25.6 |
| All Participants | Assess QOL After System Use | Background Noise (%) | 33.0 Percentage of Score (hearing problem) | Standard Deviation 20.3 |
| All Participants | Assess QOL After System Use | Ease of Communication (%) | 25.4 Percentage of Score (hearing problem) | Standard Deviation 21.7 |
| All Participants | Assess QOL After System Use | Global Score (%) | 30.3 Percentage of Score (hearing problem) | Standard Deviation 16.3 |
| All Participants | Assess QOL After System Use | Reverberation (%) | 32.4 Percentage of Score (hearing problem) | Standard Deviation 17.2 |
| None BC | Assess QOL After System Use | Global Score (%) | 55.3 Percentage of Score (hearing problem) | Standard Deviation 20.1 |
| None BC | Assess QOL After System Use | Reverberation (%) | 53.7 Percentage of Score (hearing problem) | Standard Deviation 19.8 |
| None BC | Assess QOL After System Use | Background Noise (%) | 63.6 Percentage of Score (hearing problem) | Standard Deviation 20.5 |
| None BC | Assess QOL After System Use | Ease of Communication (%) | 49.1 Percentage of Score (hearing problem) | Standard Deviation 28.3 |
| None BC | Assess QOL After System Use | Aversiveness (%) | 31.5 Percentage of Score (hearing problem) | Standard Deviation 23.7 |
Secondary
Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor
All participants were tested with both the Alpha 2 and Alpha 2 MPO processor and also with no processor (Air Conduction) and a standard lab vibration device (Bone Conduction). The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor compared to the PTA aided by Alpha 2 MPO processor.
Time frame: 1 day
Population: 69 subjects (N=72 implanted ears) were used to evaluate the primary effectiveness endpoint. 69 of 71 enrolled subjects were included in the effectiveness analysis. Two subjects did not have prospective data available: one did not have prospective audiologic exams completed and the other subject had audiologic data removed from analysis at the recommendation of the treating sub-investigator who felt the data collected to be inaccurate based on subject response.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor | 70.9 dB | Standard Deviation 16.7 |
| None BC | Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor | 33.5 dB | Standard Deviation 23.2 |
| Aided Alpha 2 | Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor | 39.5 dB | Standard Deviation 11.1 |
| Aided Alpha 2 MPO | Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor | 36.0 dB | Standard Deviation 11.1 |
Secondary
Percentage of Participants Satisfied After System Use
Subject satisfaction, via non-validated satisfaction questions
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Satisfied After System Use | Satisfied with the processor | 63 percentage of participants |
| All Participants | Percentage of Participants Satisfied After System Use | Satisfied with appearance | 74 percentage of participants |
| All Participants | Percentage of Participants Satisfied After System Use | Would recommend device to another patient | 79 percentage of participants |