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N/A N=49 Randomized Double-blind Health Services Research

Variability In Hearing Aid Outcomes In Older Adults

Hearing Loss · Presbycusis

Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Speech Intelligibility Score — 69; 78 percentage of correct responses

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Hearing Aid Fitting A (Device); Hearing Aid Fitting B (Device)
Age
Adult, Older Adult · 54+ yrs
Sex
All
Sponsor
Northwestern University
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Speech Intelligibility Score
69; 78
SECONDARY
Effectiveness of Aural Rehabilitation (EAR)
60.0; 74.2
SECONDARY
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
6.47; 6.95
SECONDARY
Adherence
9; 9

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02448706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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