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Personal Sound Amplification Device (PSAD)

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ClinicalTrials.gov Identifier: NCT03652909
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : November 16, 2021
Sponsor:
Collaborator:
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Description
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Brief Summary:
Find a personal sound amplification device that can help people hear better.

Condition or disease Intervention/treatment
Hearing Loss Device: Ascending Hearing Technologies device

Detailed Description:
Personal sound amplification devices (PSADs) have recently become available to the public. PSADs serve a potentially important role in providing audibility of sounds for adults who find themselves having difficulty hearing and understanding speech in some daily living situations, but may not be candidates for traditional, high-amplification hearing aids. Despite hearing loss being a very common problem, few adults who could benefit from some level of amplification actually access the technology. Only approximately 1 in 7 adults (14%) over the age of 50 with a hearing loss using amplification. High cost is the most commonly cited reason for not wanting to try amplification, and indeed, hearing aids range from $1000 to $5000 each (i.e., per ear). PSADs range from $50-$600 each, and may provide a reasonable option for people who are not ready, or are unwilling, to wear a hearing aid. This project aims to examine the feasibility of a PSAD to provide audible and clear sound signal to adult listeners. The significance of this project is its potential to develop an option for individuals to take advantage of amplification and access sound to improve quality of life, who may not otherwise do so without this technology.
Study Design
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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personal Sound Amplification Device
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : September 20, 2021
Actual Study Completion Date : September 20, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
PSAD
Patients try the personal sound amplification device.
 Device: Ascending Hearing Technologies device
Personal Sound Amplification Device


Outcome Measures
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Primary Outcome Measures :
  1. Likert Scale [ Time Frame: The patient will wear the personal sound amplification device on average for 30 minutes. ]

    The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device.

    The patient will rate the following questions on a scale from Strongly Agree, Disagree, Neutral, Agree, and Strongly Disagree for the following statements:

    1. The words were clear.
    2. The sentences were easy to understand.
    3. The words sounded distorted.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Those with hearing issues.
Criteria

Inclusion Criteria:

  • Adults who report difficulty hearing in some daily listening situations.
  • Primarily English-speaking
  • Able to follow instructions and perform study procedures.

Exclusion Criteria:

  • Children
  • Non-English speaking
  • Unable to perform research procedures and/or follow necessary instructions
Contacts and Locations
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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): NCT03652909


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
University of Wisconsin, Milwaukee
Investigators
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Principal Investigator: Christina L Runge, PhD Medical College of Wisconsin
More Information
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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03652909    
Other Study ID Numbers: PRO00032080
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases