NCT00438334

Brief Summary

Directional microphone hearing aids have been shown to provide benefit for individuals with hearing loss in a number of laboratory experiments. However, few studies have investigated the real-world, subject-reported benefit from these hearing aids, and even fewer have examined directional hearing aid benefit across varying degrees of hearing loss. This study will summarize data from a three-year, multi-faceted study of directional hearing aid benefit. Ninety four subjects were divided into three hearing loss groups (normal-to-moderate, mild-to-moderately-severe, and moderate-to-profound). These subjects were then fit with experimental hearing aids set to either directional or omnidirectional mode to determine if significant differences were present in hearing aid outcomes (both subjective and objective). Both subject and experimenter were blinded to the hearing aid settings. Following one month of use in each experimental setting, subjects completed: probe microphone measurements, speech understanding in noise testing, use questionnaires, subjective benefit scales, and satisfaction scales. At the conclusion of the study, subjects rated their preferences for the experimental settings in quiet, noise and overall. Both objective measures, as well as subjective data, were analyzed across hearing aid and hearing loss conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2006

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

December 5, 2006

Last Update Submit

November 18, 2016

Conditions

Hearing Loss

Keywords

BenefitDirectional microphonesHearingHearing aidsHearing lossNoiseObjective benefitSignal-to-noise ratioSpeech understandingSubjective benefit

Outcome Measures

Primary Outcomes (6)

  • Probe microphone measurements

  • Speech understanding in noise

  • Hearing aid use time

  • Hearing aid benefit

  • Hearing aid preference

  • Hearing aid satisfaction

Interventions

Programmable directional/omni-directional hearing aidDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjects were recruited for participation in this study, thirty-five in each of three hearing loss groups.
  • Subjects were assigned to the three groups according to the severity of their hearing losses.
  • Group 1 (mild) subjects exhibited normal sloping to moderately severe SNHL, with Pure Tone Averages (PTAs) at 500, 1000, and 2000 Hz of less than 35 dB HL.
  • Group 2 (moderate) consisted of subjects with mild sloping to moderately severe SNHL with PTAs of 35 to 50 dB HL.
  • Group 3 (severe) subjects exhibited moderately-severe, sloping to severe-profound SNHL, with PTAs of greater than 50.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Veterans Affairs Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Gnewikow D, Ricketts T, Bratt GW, Mutchler LC. Real-world benefit from directional microphone hearing aids. J Rehabil Res Dev. 2009;46(5):603-18. doi: 10.1682/jrrd.2007.03.0052.

    PMID: 19882494DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Gnewikow, Ph.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2006

First Posted

February 22, 2007

Study Start

April 1, 2001

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

US(1)