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OpenTrials
Completed

NCT Number: NCT03143257

Ambispective Clinical Evaluation of Sophono™

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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Key information

Conditions

Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Mixed Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Single-sided Deafness

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Macias Otology, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sophono Bone Conduction Hearing Systems

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.

Primary outcomes

  1. Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant

    Time frame: From Implantation to Study Visit, up to 6 years

    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.

  2. Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor

    Time frame: 1 day

    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.

Secondary outcomes

  1. Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor

    Time frame: 1 day

    All participants were tested with both the Alpha 2 and Alpha 2 MPO processor and also with no processor (Air Conduction) and a standard lab vibration device (Bone Conduction). 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.

  2. Percentage of Participants Satisfied After System Use

    Time frame: 1 day

    Subject satisfaction, via non-validated satisfaction questions

  3. Assess QOL After System Use

    Time frame: 1 day

    QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment. The APHAB is a questionnaire with four subscales (Ease of Communication, Reverberation, Background Noise, and Aversiveness). Items are answered on a seven-point scale from "always" to "never". Scores for subscales can range from 0% (no difficulty) to 99% (maximum difficulty). Negative scores reflect a better benefit from aided hearing all subcategories are reported in percentiles. Abbreviated Profile of Hearing Aid Benefit was taken at 1 time point. Per request of site Institutional Review Board (IRB) pediatric patients were given a pediatric version. Calculation compared aided to unaided hearing.

    A global score is computed by averaging the East of Communication, Reverberation, and Background Noise scale scores. Questions are answered for unaided and aided listening. Aided scores are subtracted from unaided scores.

Sponsors and collaborators

Lead sponsor

Medtronic Surgical Technologies

Industry

Registry information

Acronym: ACES

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 8, 2017
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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