Ambispective Clinical Evaluation of Sophono™

Conductive Hearing Loss Clinical Trial

— ACES  

Official title:

Ambispective Clinical Evaluation of Sophono™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143257
• Other study ID #: MDT16043ENT
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Mixed Hearing Loss
• Single-Sided Deafness

Intervention

Device:
• Sophono Bone Conduction Hearing Systems
The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of 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.

Locations

Country	Name	City	State
United States	UF Health ENT and Allergy	Gainesville	Florida
United States	Nemours Children's Specialty Care	Jacksonville	Florida
United States	Park Avenue Otology/Neurotology	New York	New York
United States	Macias Otology	Phoenix	Arizona
United States	Pittsburgh Ear Associates	Pittsburgh	Pennsylvania
United States	Carolina Ear & Hearing Clinic	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety of the 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 ENT exam.	From Implantation to Study Visit, up to 6 years
Primary	Assess the effectiveness of the Sophono Alpha 2 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.	1 day
Secondary	Compare the effectiveness of the Sophono Alpha 2 processor to the Alpha 2 MPO processor	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	1 day
Secondary	Assess the effectiveness of the Sophono Alpha 2 and the Sophono Alpha 2 MPO over time	Change over time of PTA in the Sophono Alpha 2 and Alpha 2 MPO	From Processor fitting to Study Visit, up to 4 years
Secondary	Assess subject satisfaction after system use	Subject satisfaction, via non-validated satisfaction questions	1 day
Secondary	Assess QOL after system use	QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment	1 day