Ambispective Clinical Evaluation of Sophono™

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-29

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Conductive Hearing Loss Single-Sided Deafness Mixed Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Sophono Bone Conduction Hearing Systems

Intervention Type DEVICE

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.

Interventions

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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 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No