NCT00738244

Brief Summary

Wind-noise is highly disturbing to hearing impaired individuals wearing hearing aids who wish to participate in outdoor conversations where wind is present or during activities such as walking or running. In these situations, wind noise significantly reduces signal-to-noise ratio and, consequently, the intelligibility of speech and sounds may be significantly impaired. This negative effect is exacerbated with the use of directional microphone schemes in the hearing iads. The objective of this project is to determine the efficacy of the MH Acoustics' multi-microphone wind-noise reduction invention for the digital hearing aids market. MH Acoustics' wind noise reduction technology is unique since it provides instantaneous convergence while maintaining directionality of the microphone array. Current commercial technologies do not provide this feature. We are hypothesizing that, due to the design of the algorithm, speech perception ability and sound quality perception will be better than that available with traditional directional and/or omnidirectional microphone schemes in windy environments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

August 18, 2008

Last Update Submit

September 23, 2011

Conditions

Keywords

hearing aid algorithmwind-noise suppression

Outcome Measures

Primary Outcomes (1)

  • Speech Perception as measured by the Connected Speech Test (Cox et al)

    Each of three follow-up visits

Secondary Outcomes (1)

  • Sound Quality

    Each of three follow-up visits

Study Arms (2)

1

Normal hearing listeners

2

Listeners with mild-to-moderate sensorineural hearing loss

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups (30 each) of subjects will be recruited to participate: Normal hearing adults and adults with mild to moderately severe hearing loss, ages 18-65. Pure tone audiometrics (re ANSI, 1996) will be done to ascertain the hearing sensitivity through 6ooo Hz. Normal hearing will be defined as thresholds at or better than 20 dB HL (re ANSI, 1996). The only exclusion criterion for the group exhibiting hearing loss is that no thresholds up to and including 3000 Hz will exceed 75 dB, so as to minimize the inclusion of subjects with "dead regions" in the cochlea.

You may qualify if:

  • Ages 18-75
  • Normal or mild-to-moderate sensorineural hearing loss

You may not qualify if:

  • Thresholds in excess of 75 dB HL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wendell Johnson Center, University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ruth A Bentler, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations