Trial Outcomes & Findings for Ambispective Clinical Evaluation of Sophono™ (NCT NCT03143257)

NCT ID: NCT03143257

Last Updated: 2024-07-05

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 71 participants
• Primary outcome timeframe: From Implantation to Study Visit, up to 6 years
• Results posted on: 2024-07-05

Participant Flow

Participant milestones

Measure	Sophono Implant All Study Participants that have had a previous Sophono Bone Conduction Hearing System implant. No interventions were administered.
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ambispective Clinical Evaluation of Sophono™

Baseline characteristics by cohort

Measure	All Participants n=74 Ears All Study Participants
Age, Continuous	23.1 years n=71 Participants
Sex: Female, Male Female	48 Participants n=71 Participants
Sex: Female, Male Male	23 Participants n=71 Participants
Region of Enrollment United States	71 Participants n=71 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Participants n=71 Participants All Study Participants	None BC Unaided without the processor (Bone Conduction)	Aided Alpha 2 Aided Alpha 2	Aided Alpha 2 MPO Aided Alpha 2 MPO Processor
Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant	0.038 Proportion of Adverse Events Interval 0.018 to 0.07	—	—	—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	All Participants n=70 Ears All Study Participants	None BC n=70 Ears Unaided without the processor (Bone Conduction)	Aided Alpha 2 n=70 Ears Aided Alpha 2	Aided Alpha 2 MPO n=70 Ears Aided Alpha 2 MPO Processor
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	41.2 decibles Standard Deviation 26.8	39.4 decibles Standard Deviation 11.2	35.7 decibles Standard Deviation 11.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	All Participants n=72 ears All Study Participants	None BC n=70 ears Unaided without the processor (Bone Conduction)	Aided Alpha 2 n=70 ears Aided Alpha 2	Aided Alpha 2 MPO n=70 ears Aided Alpha 2 MPO Processor
Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor	70.9 dB Standard Deviation 16.7	33.5 dB Standard Deviation 23.2	39.5 dB Standard Deviation 11.1	36.0 dB Standard Deviation 11.1

SECONDARY outcome

Timeframe: 1 day

Subject satisfaction, via non-validated satisfaction questions

Outcome measures

Measure	All Participants n=68 Participants All Study Participants	None BC Unaided without the processor (Bone Conduction)	Aided Alpha 2 Aided Alpha 2	Aided Alpha 2 MPO Aided Alpha 2 MPO Processor
Percentage of Participants Satisfied After System Use Satisfied with the processor	63 percentage of participants	—	—	—
Percentage of Participants Satisfied After System Use Satisfied with appearance	74 percentage of participants	—	—	—
Percentage of Participants Satisfied After System Use Would recommend device to another patient	79 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 1 day

Population: In this study 63 of 71 subjects completed the APHAB.

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.

Outcome measures

Measure	All Participants n=63 Subject Responses All Study Participants	None BC n=63 Subject Responses Unaided without the processor (Bone Conduction)	Aided Alpha 2 Aided Alpha 2	Aided Alpha 2 MPO Aided Alpha 2 MPO Processor
Assess QOL After System Use Ease of Communication (%)	25.4 Percentage of Score (hearing problem) Standard Deviation 21.7	49.1 Percentage of Score (hearing problem) Standard Deviation 28.3	—	—
Assess QOL After System Use Reverberation (%)	32.4 Percentage of Score (hearing problem) Standard Deviation 17.2	53.7 Percentage of Score (hearing problem) Standard Deviation 19.8	—	—
Assess QOL After System Use Background Noise (%)	33.0 Percentage of Score (hearing problem) Standard Deviation 20.3	63.6 Percentage of Score (hearing problem) Standard Deviation 20.5	—	—
Assess QOL After System Use Aversiveness (%)	44.3 Percentage of Score (hearing problem) Standard Deviation 25.6	31.5 Percentage of Score (hearing problem) Standard Deviation 23.7	—	—
Assess QOL After System Use Global Score (%)	30.3 Percentage of Score (hearing problem) Standard Deviation 16.3	55.3 Percentage of Score (hearing problem) Standard Deviation 20.1	—	—

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=71 participants at risk All Study Participants
Skin and subcutaneous tissue disorders Implant Site Pain	2.8% 2/71 • 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.
Skin and subcutaneous tissue disorders Incision Site Erythema	1.4% 1/71 • 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.
Skin and subcutaneous tissue disorders Medical Device Site Discomfort	5.6% 4/71 • 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.
Skin and subcutaneous tissue disorders Skin Hypertrophy	1.4% 1/71 • 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.
Skin and subcutaneous tissue disorders Skin Irritation	1.4% 1/71 • 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.

Additional Information

Sr Manager, Clinical Affairs

Medtronic Xomed

Phone: 904-296-9600

Email: rs.entgm@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60