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Morphology Effects of Extended Wear Hearing Instrument

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902093
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kristina Rousso, University of Southern California

Brief Summary:

The lyric hearing device is a commercially available device produced by Sonova, and designed to be used for extended periods of time. We further want to investigate the morphology of the tissue around the device at different periods of time after the device has been fitted and used for a while.

An initial imaging of the tissue will be taken for baseline measurements. Questionnaires will also be used to assess patients satisfaction with the device and cognitive abilities.


Condition or disease Intervention/treatment Phase
Hearing Loss Diagnostic Test: Morphology changes with extended wear hearing aid Not Applicable

Detailed Description:

If the person seems to be a good candidate for the study, the Audiologist could discuss with the patient the time involved in the study and arrange an appointment with the patient if interested.

A series of appointments are designed to follow up the patient's development with the device at determined times during the process. On the first appointment the patient will be consented prior to any tests or health services given.

The first and last appointments are the longest ones with a duration of about 1 and a half hours for questionnaires, medical history, and device fitting. Additionally, all appointments include measurement of ear canal relative humidity which should take a total of 30 minutes and imaging of the area to determine thickness and blood flow in the tissue surrounding the device. Follow-up appointments with the Audiologist will take 45 minutes for all basic procedures. The Lyric device is used commercially and Audiologist can provide it to patients already, but the purpose of this study is to use a pioneer technique with a device that looks inside the ear canal in the same way as a regular used speculum to look at details of the tissue around the device to see if any changes occur due to extended wear of the Lyric hearing aid device.

The complete study per person will be completed in about six months. An Audiologist will perform all the audiology testing plus the ear canal humidity measurements and his/her time will be covered by the sponsor (a total of 9 hours per patient). The Lyric devices will be provided on loan by the sponsor as well as the equipment and software needed to make the ear canal humidity measurements. The imaging measurements will be conducted by the Audiologist trained in using the handheld device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Longitudinal Study of External Auditory Canal Morphology With Regards to Extended-wear Hearing Instrument
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hearing Aid
Actual Patients in the clinic will be evaluated by their Audiologist, if they are candidates to use the Lyric Hearing aid they will be asked if they want to participate in the study which will include imaging of the ear canal with a device similar to the regular ear device used in the clinic to check if there are any changes to the morphology of the ear canal.
Diagnostic Test: Morphology changes with extended wear hearing aid
Possible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging




Primary Outcome Measures :
  1. Morphology imaging [ Time Frame: Complete study will take about six months per person ]
    Imaging of the tissue at each appointment will be made



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients in the USC Otolaryngology Clinic who are determined to be candidates for a Lyric extended wear hearing aid device by their treating Audiologist (in general people with mild to moderate hearing loss may be eligible).

Exclusion Criteria:

  • Patients in the USC Clinic who are determined by the Audiologist not to be good candidates for the Hearing aid extended wear device (in general, people with severe hearing loss are not eligible).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902093


Contacts
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Contact: Kristina Rousso, AuD 213-764-2817 kristina.rousso@med.usc.edu

Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Kristina Rousso, AuD University of Southern California
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Responsible Party: Kristina Rousso, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03902093    
Other Study ID Numbers: HS-19-00205
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kristina Rousso, University of Southern California:
hearing loss, hearing aid
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases