Personal Sound Amplification Smartphone Application Feasibility

NCT ID: NCT03652909

Last Updated: 2023-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-26

Study Completion Date

2021-09-20

Brief Summary

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Find a personal sound amplification device that can help people hear better.

Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults with difficulty hearing in some daily listening situations

Patients listen to sounds with and without the personal sound amplification smartphone application

Ascending Hearing Technologies device

Intervention Type DEVICE

Personal Sound Amplification Device

Interventions

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Ascending Hearing Technologies device

Personal Sound Amplification Device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Milwaukee

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina L Runge, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R41DC017939

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00032080

Identifier Type: -

Identifier Source: org_study_id

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