Ambispective Clinical Evaluation of Sophono™ (ACES)

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.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Single-Sided Deafness; Mixed Hearing Loss
• Intervention / Treatment: Device: Sophono Bone Conduction Hearing Systems

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Macias Otology
  • Florida
    • Gainesville, Florida, United States, 32607
      • UF Health ENT and Allergy
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Specialty Care
  • New York
    • New York, New York, United States, 10075
      • Park Avenue Otology/Neurotology
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Carolina Ear & Hearing Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Pittsburgh Ear Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Subjects; Diagnosed with CHL, SSD and mixed HL who currently have or have had the Sophono implant

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Assess subject satisfaction 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	1 day

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2017
• Primary Completion (ACTUAL): May 31, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: MDT16043ENT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes