Clinical trial NCT03652909: Personal Sound Amplification Smartphone Application Feasibility
Official title: Personal Sound Amplification Smartphone Application Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-08-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who report difficulty hearing in some daily listening situations

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

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.

Eligibility 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

Primary outcomes:
measure: Sentence Perception in Noise Fine-tuned v Unamplified
timeFrame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
measure: Sentence Perception in Noise Initial Fit v Unamplified
timeFrame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Secondary outcomes:
measure: Words Clear
timeFrame: The patient will wear the personal sound amplification device on average for 30 minutes.
measure: Sentences Easy to Understand
timeFrame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
measure: Sounds Are Distorted
timeFrame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Christina L Runge, PhD
role: PRINCIPAL_INVESTIGATOR
References: