Ambispective Clinical Evaluation of Sophono™ (ACES)

Medtronic

Status: Completed

Conditions: Mixed Hearing Loss; Single-Sided Deafness; Conductive Hearing Loss

Treatments: Device: Sophono Bone Conduction Hearing Systems

Study type: Observational

Funder types: Industry

Identifiers

NCT03143257

MDT16043ENT

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

71 participants in 1 patient group

Subjects

Description:

Diagnosed with Conductive Hearing Loss (CHL), Single-Sided Deafness (SSD)and mixed Hearing Loss (HL) who currently have or have had the Sophono implant

Treatment:

Device: Sophono Bone Conduction Hearing Systems