Variability In Hearing Aid Outcomes In Older Adults

Hearing Loss Clinical Trial

Official title:

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448706
• Other study ID #: 1R01DC012289-01
• Secondary ID: 1R01DC012289-01
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 54 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss
• Presbycusis

Intervention

Device:
• Hearing Aid Fitting A

• Hearing Aid Fitting B

Locations

Country	Name	City	State
United States	University of Colorado at Boulder	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Intelligibility Score	Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.	6 weeks
Secondary	Effectiveness of Aural Rehabilitation (EAR)	The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).	6 weeks
Secondary	Speech and Spatial Qualities of Hearing (SSQ) Questionnaire	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.	6 weeks
Secondary	Adherence	Average number of hours per day the hearing aid was worn.	6 weeks