Personal Sound Amplification Smartphone Application Feasibility

Hearing Loss Clinical Trial

— PSAD  

Official title:

Personal Sound Amplification Smartphone Application Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652909
• Other study ID #: PRO00032080
• Secondary ID: R41DC017939
• Status: Completed
• Start date: February 26, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: January 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Ascending Hearing Technologies device
Personal Sound Amplification Device

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentence Perception in Noise Fine-tuned v Unamplified	The fine-tuned Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.	The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Primary	Sentence Perception in Noise Initial Fit v Unamplified	The prescription gain (initial fit) Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.	The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Secondary	Words Clear	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 Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Higher values mean better outcome.	The patient will wear the personal sound amplification device on average for 30 minutes.
Secondary	Sentences Easy to Understand	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 Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'sentences were easy to understand.' Higher values mean better outcome.	The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Secondary	Sounds Are Distorted	The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Lower values mean better outcome.	The patient will wear the Personal Sound Amplification Device for approximately 30 minutes