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Personal Sound Amplification Device (PSAD)

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: NCT03652909
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
Medical College of Wisconsin

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.

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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personal Sound Amplification Device
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




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 who 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Sarah E Mleziva, BS 4149550822 smleziva@mcw.edu

Sponsors and Collaborators
Medical College of Wisconsin
University of Wisconsin, Milwaukee

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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: February 13, 2020
Last Verified: February 2020
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
Signs and Symptoms