Hearing ImpairmentNCT00738244
Effectiveness of Hearing-aid Based Wind-noise Algorithm
An observational study of Hearing Impairment, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Ages 18-75
- Normal or mild-to-moderate sensorineural hearing loss
Who cannot join
- Thresholds in excess of 75 dB HL
Trial locations and contacts
1 site in 1 country.
United States1 site
Wendell Johnson Center, University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hearing Impairment
- Keywords
- hearing aid algorithm, wind-noise suppression
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal hearing listeners | |
| 2 | Listeners with mild-to-moderate sensorineural hearing loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Perception as measured by the Connected Speech Test (Cox et al)
Measured: Each of three follow-up visits
Secondary outcomes (1)
Sound Quality
Measured: Each of three follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Ruth Ann Bentler, University of Iowa
- Investigators
- Ruth A Bentler, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738244
- Sponsor's protocol ID
- 2R44DC007246-02A2
- Other IDs
- R44DC007246
- Status last verified
- Sep 2011
- First submitted
- 18 Aug 2008
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods of Wind Noise Suppression in Hearing Aids
- ClinicalTrials.gov ID
- NCT00738244
- Acronym / sponsor ID
- 2R44DC007246-02A2
- Conditions
- Hearing Impairment
- Keywords
- hearing aid algorithm, wind-noise suppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Normal hearing listeners |
| 2 | – | –Listeners with mild-to-moderate sensorineural hearing loss |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Ages 18-75
- Normal or mild-to-moderate sensorineural hearing loss
Key exclusion criteria (1 listed)
- Thresholds in excess of 75 dB HL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Speech Perception as measured by the Connected Speech Test (Cox et al)
Time frame: Each of three follow-up visits
1 secondary outcome
Sound Quality
Time frame: Each of three follow-up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
Related trials for Hearing Impairment
Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth A Bentler, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Impairment, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Perception as measured by the Connected Speech Test (Cox et al) (time frame: Each of three follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.