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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects | Diagnosed with Conductive Hearing Loss (CHL), Single-Sided Deafness (SSD)and mixed Hearing Loss (HL) who currently have or have had the Sophono implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sophono Bone Conduction Hearing Systems | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Implantation to Study Visit, up to 6 years |
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population for this study includes male and female patients 5 years of age and older who have received the Sophono implant. Subjects will be recruited from Investigators who have implanted Sophono systems or from other non-investigator physician referrals. Subjects are expected to represent a population diagnosed with conductive hearing loss (CHL), single-sided deafness (SSD), and mixed hearing loss (HL).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macias Otology | Phoenix | Arizona | 85006 | United States | ||
| UF Health ENT and Allergy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sophono Implant | All Study Participants that have had a previous Sophono Bone Conduction Hearing System implant. No interventions were administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
71 participants were enrolled, 3 presented with bilateral device use which amounted to 74 enrolled ears.
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | Proportion of Adverse Events | From Implantation to Study Visit, up to 6 years |
|
|
Adverse Events were collected from each subject at the single study visit which occurred at a range of 3 months to 5 years post-implantation. The collective Adverse Events in this study represent a range of time from implantation to the study visit (3 months to 5 years post implantation).
All adverse events present at the prospective visit were collected. Only treatment (surgical procedure or device) related events were collected retrospectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All Study Participants | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Pain | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Manager, Clinical Affairs | Medtronic Xomed | 904-296-9600 | rs.entgm@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2017 | Feb 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2018 | May 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| 1 day |
| Percentage of Participants Satisfied After System Use | Subject satisfaction, via non-validated satisfaction questions | 1 day |
| 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. | 1 day |
| Gainesville |
| Florida |
| 32607 |
| United States |
| Nemours Children's Specialty Care | Jacksonville | Florida | 32207 | United States |
| Park Avenue Otology/Neurotology | New York | New York | 10075 | United States |
| Carolina Ear & Hearing Clinic | Raleigh | North Carolina | 27609 | United States |
| Pittsburgh Ear Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Ears |
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| years |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | decibles | 1 day | Ears | Ears |
|
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | dB | 1 day | ears | ears |
|
|
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| Secondary | Percentage of Participants Satisfied After System Use | Subject satisfaction, via non-validated satisfaction questions | Posted | Number | percentage of participants | 1 day |
|
|
|
| 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. | In this study 63 of 71 subjects completed the APHAB. | Posted | Mean | Standard Deviation | Percentage of Score (hearing problem) | 1 day | Subject Responses | Subject Responses |
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| 71 |
| 0 |
| 71 |
| 9 |
| 71 |
| Incision Site Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Medical Device Site Discomfort | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin Hypertrophy | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ears |
|
| Mean Difference (Net) |
| 43.5 |
| Standard Deviation |
| 20.0 |
| 2-Sided |
| Superiority |
| Wilcoxon (Mann-Whitney) | < 0.0001 | Mean Difference (Net) | 3.7 | Standard Deviation | 5.0 | 2-Sided | Superiority |
| ears |
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| Background Noise (%) |
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| Aversiveness (%) |
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| Global Score (%) |
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