Ambispective Clinical Evaluation of Sophono™

Completed

• Conditions: Mixed Hearing Loss; Conductive Hearing Loss; Single-Sided Deafness
• Interventions: Device: Sophono Bone Conduction Hearing Systems

• Registration Number: NCT03143257
• Lead Sponsor: Medtronic Surgical Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Study Start: 2017-06-29
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Results First Submitted: 2019-02-13
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Results First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects	Sophono Bone Conduction Hearing Systems	Diagnosed with Conductive Hearing Loss (CHL), Single-Sided Deafness (SSD)and mixed Hearing Loss (HL) who currently have or have had the Sophono implant

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Macias Otology; 🇺🇸 Phoenix, Arizona, United States

Park Avenue Otology/Neurotology; 🇺🇸 New York, New York, United States

UF Health ENT and Allergy; 🇺🇸 Gainesville, Florida, United States

Nemours Children's Specialty Care; 🇺🇸 Jacksonville, Florida, United States

Carolina Ear & Hearing Clinic; 🇺🇸 Raleigh, North Carolina, United States

Pittsburgh Ear Associates; 🇺🇸 Pittsburgh, Pennsylvania, United States