Skip to main content
OpenTrials
Completed

NCT Number: NCT02448706

Variability In Hearing Aid Outcomes In Older Adults

The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.

Completed

Looking for future studies?

Notify Me

Key information

Age range

54 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado at Boulder

Boulder, Colorado, 80309, United States

About this study

Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL
  • Non hearing aided wearer within the previous year
  • Participants will be in good health (self-report)
  • Normal or corrected to normal vision(≤20/50)

Exclusion criteria

  • Conductive, or asymmetric hearing loss
  • Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
  • Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
  • Significant history of otologic or neurologic disorders
  • Non English speaking participants
  • Score of 23 or below on Mini-Mental Status Exam (MMSE)
  • Score of 22 or below on Montreal Cognitive Assessment (MoCA)
  • Any clinically significant unstable or progressive medical condition
  • Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
  • Participants will be divided into low and high working groups based upon the results of their Lunner working memory reading span test. Once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.

Treatment and study plan

Hearing Aid Fitting A

Device

Other names: Hearing Aid

Hearing Aid Fitting B

Device

Primary outcomes

  1. Speech Intelligibility Score

    Time frame: 6 weeks

    Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.

Secondary outcomes

  1. Effectiveness of Aural Rehabilitation (EAR)

    Time frame: 6 weeks

    The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).

  2. Speech and Spatial Qualities of Hearing (SSQ) Questionnaire

    Time frame: 6 weeks

    Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.

  3. Adherence

    Time frame: 6 weeks

    Average number of hours per day the hearing aid was worn.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 19, 2015
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.