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Completed

NCT Number: NCT05349981

Lyric Self-replacement Clinical Investigation

This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Audiology, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Meets requirements outlined on Lyric self-replacement candidacy form
  • Current Lyric hearing instrument user with 3+ months of Lyric experience
  • 22 years of age or older at the time of enrollment in the study
  • Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally)
  • Good understanding (read/write/speak) of the English language
  • Willingness to comply with all study requirements

Exclusion criteria

  • Does not meet requirements outlined on Lyric self-replacement candidacy form
  • Difficulty understanding/reading instructions when corrected for vision loss
  • Impairments that would restrict participation in any of the evaluations
  • Ear health conditions present at baseline that prevent immediate device replacement
  • Conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations

Treatment and study plan

Phonak Lyric self-replacement procedure

Device

The self-replacement procedure is an experimental procedure in which the Lyric user replaces the Lyric devices independently at every other device replacement, using dedicated candidacy, training, and management procedures, conducted by and at the discretion of his/her hearing care provider (HCP).

Primary outcomes

  1. Change in aided audiometric threshold testing between standard and experimental replacement procedures

    Time frame: Baseline, during intervention, immediately after intervention

    Aided audiometric test measures: threshold testing. Thresholds will be measured in decibels Hearing Level (dBHL), with a range of -10 - 120 dBHL. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.

  2. Change in aided speech-in-noise testing between standard and experimental replacement procedures

    Time frame: Baseline, during intervention, immediately after intervention

    Aided audiometric test measures: speech-in-noise testing. Scores will be measured using signal-to-noise ratio loss, with scores ranging from 0 - 25.5. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.

Secondary outcomes

  1. Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures

    Time frame: Through study completion, an average of 5 months

    Evaluation of incidence of medical referral secondary to device replacement, as determined necessary by the hearing care professional, and compared between the standard and experimental device replacement procedures

Other outcomes

  1. Change in incidence of provider/clinical support needed across device replacement procedures

    Time frame: Through study completion, an average of 5 months

    Evaluation of incidence of provider/clinical support needed between device replacements, as recorded by study staff, and compared between time periods associated with the standard and experimental device replacement procedures

  2. Change in incidence of acoustic feedback across device replacement procedures

    Time frame: Baseline, during intervention, immediately after intervention

    Evaluation of incidence of acoustic feedback secondary to device replacement, as subjectively reported by the end user, and compared between the standard and experimental device replacement procedures

  3. Change in measured device position at replacement between standard and experimental replacement procedures

    Time frame: Baseline, during intervention, immediately after intervention

    Achieved insertion depth of device, as measured by the hearing care professional using the dedicated fitting tool, and compared between the standard and experimental fitting procedures.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • AccuData Solutions

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Jul 12, 2023

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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