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OpenTrials
Completed

NCT Number: NCT04882800

Evaluation of Extended Wear Technology

Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.

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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

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Main Line Audiology Consultants

Narberth, Pennsylvania, 19072, United States

About this study

A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mild, Moderate and Moderate Severe Hearing loss
  • Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues

Exclusion criteria

  • Participants who can only wear a size XXS (extra-extra small) extended wear device
  • asymmetrical hearing loss
  • other diagnosis that may cause hearing fluctuation
  • inability to tolerate physical fit of Lyric devices
  • inability to be seen for four lab visits

Treatment and study plan

Lyric extended wear hearing aid device A

Device

Current commercially available extended wear hearing aid

Lyric extended wear hearing aid with fitting modification device B

Device

Extended wear hearing aid with fitting modifications

Primary outcomes

  1. Subjective Questionnaire of Comfort

    Time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)

    Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.

  2. Subjective Ratings of Occlusion With Both Devices

    Time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)

    Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

Evaluation of Fitting Modification for Extended Wear Technology

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
Dec 14, 2022

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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