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OpenTrials
Completed

NCT Number: NCT06597747

Design Improvements With SONNET 3

Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

About this study

This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Implanted with a MED-EL cochlear implant in at least one ear
  • ≥ 12 months since activation of the MED-EL audio processor
  • Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
  • Ability to complete all study procedures
  • Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study

Exclusion criteria

  • Evidence that hearing loss is retrocochlear in origin
  • Unable to provide reliable feedback during cochlear implant programming
  • Skin or scalp condition precluding use of the study device
  • Unrealistic participant or parent (if applicable) motivation or expectations
  • Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.

Treatment and study plan

Audio processor

Device

MED-EL SONNET 3 (EAS) audio processor

Primary outcomes

  1. Participants Reporting Improvement With SONNET 3 Design

    Time frame: Measured 1 month after baseline

    The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey

Secondary outcomes

  1. Audiologist Satisfaction Ratings

    Time frame: Measured after study completion, an average of 7.5 months

    Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Official study title

Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Dec 31, 2025

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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