Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effectiveness of Hearing-aid Based Wind-noise Algorithm

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ruth Ann Bentler, University of Iowa
ClinicalTrials.gov Identifier:
NCT00738244
First received: August 18, 2008
Last updated: September 23, 2011
Last verified: September 2011

August 18, 2008
September 23, 2011
November 2007
November 2009   (final data collection date for primary outcome measure)
Speech Perception as measured by the Connected Speech Test (Cox et al) [ Time Frame: Each of three follow-up visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738244 on ClinicalTrials.gov Archive Site
Sound Quality [ Time Frame: Each of three follow-up visits ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Hearing-aid Based Wind-noise Algorithm
Methods of Wind Noise Suppression in Hearing Aids

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.

Two groups 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.

Subjects will be seen for four visits to the laboratory. The first visit will involve documentation of informed consent, and measurement of hearing thresholds. The second, third and fourth visits will consist of testing with the following measures (in random order for each subject) to determine if the various implementations of the wind noise reduction algorithm 1) impact speech perception ability, and/or 2) impact sound quality perception. Each session will take approximately 1.5 hours, with a maximum of six hours over all the sessions. The two speech perception tests that will be utilized include : 1) Connected Speech Test and Hearing in Noise Test, 2) The Hearing in Noise Test (HINT) (Nilsson, Soli, & Sullivan, 1994; Koch, Nilsson & Soli, 1995. Overall Impression of Sound Quality and Ratings of Annoyance will be used as subjective, or self-reported, measures of preference. Overall Impression will be influenced by the audibility and masking effect of the noise bursts, whereas Annoyance ratings are significantly correlated to the high frequency emphasis of the stimulus, a potential impact of the extreme suppression conditions (e.g., -18 dB) (Warner & Bentler, 2002; Miedema & Vos, 2003). Both measures will be analyzed as a function of the different time constants, gain reduction levels, and level of presentation.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Hearing Impairment
Not Provided
  • 1
    Normal hearing listeners
  • 2
    Listeners with mild-to-moderate sensorineural hearing loss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Thresholds in excess of 75 dB HL
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00738244
2R44DC007246-02A2, R44DC007246
No
Ruth Ann Bentler, University of Iowa
University of Iowa
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Ruth A Bentler, PhD University of Iowa
University of Iowa
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP