Ambispective Clinical Evaluation of Sophono™
ACES
1 other identifier
observational
71
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedStudy Start
First participant enrolled
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedResults Posted
Study results publicly available
July 5, 2024
CompletedJuly 5, 2024
January 1, 2024
11 months
May 1, 2017
February 13, 2019
January 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor
1 day
Percentage of Participants Satisfied After System Use
1 day
Assess QOL After System Use
1 day
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Macias Otology
Phoenix, Arizona, 85006, United States
UF Health ENT and Allergy
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr Manager, Clinical Affairs
- Organization
- Medtronic Xomed
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 8, 2017
Study Start
June 29, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
July 5, 2024
Results First Posted
July 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share