Hearing LossNCT00371449
Predicting Success With Hearing Aids
An observational study of Hearing Loss and Presbycusis, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary complaint of individuals with hearing loss is difficulty understanding speech in the presence of background noise. Although hearing aids help individuals understand speech in background noise better, there is a high rate of hearing aid rejection in part due to continued difficulty understanding speech in… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Presbycusis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jun 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults with sensorineural hearing loss
Who may be able to join
- adult onset of hearing loss,
- symmetrical, sensorineural hearing loss,
- no more than 60 dB HL hearing loss measured via an average of air conduction thresholds at .5, 1, and 2 kHz in each ear, and
- use of binaural hearing aids of the same make and model for each ear
- at least 3 months of hearing aid use.
Who cannot join
- enrollment in group audiologic rehabilitation classes,
- currently using an FM system,
- inability to read and write American English, and
- signs of middle ear or retrocochlear pathology.
Trial locations and contacts
1 site in 1 country.
United States1 site
James H. Quillen VA Medical Center
Mountain Home, Tennessee, 37684
About this study
Official title: Speech-in-Noise Measures as a Predictor of Hearing Aid Outcomes
The primary complaint of individuals with hearing loss is difficulty understanding speech in the presence of background noise. Although hearing aids help individuals understand speech in background noise better, there is a high rate of hearing aid rejection in part due to continued difficulty understanding speech in complex listening situations. The results of this study may demonstrate that speech-in-noise test results can be a predictor of hearing aid success. The results of this study also may lead to further studies that can evaluate interventions to improve hearing aid success for individuals who are identified as unsuccessful hearing aid users.
Read the detailed description
As numerous studies have reported, the most common complaint that individuals with sensorineural hearing loss have about their hearing is that they can hear speech but they cannot understand speech, especially in background noise. For this type of hearing loss and most other types of hearing losses, hearing aids are the intervention of choice. The majority of individuals who receive hearing aids are successful hearing-aid users in that both subjectively and objectively they function better with their hearing aids than without hearing aids. Other individuals are unsuccessful hearing-aid users because for a variety of reasons their perception is that the hearing aids do not enable them to function better. Two studies (Popelka et al., 1998; Kockchin, 2000) indicate that about 25% of individuals who receive hearing aids can be considered unsuccessful hearing-aid users. If potentially (un)successful hearing-aid users can be identified, then audiologic rehabilitation programs can be designed for use with potentially successful hearing-aid users and more extensive audiologic rehabilitation programs can be designed for use with those individuals who are potentially unsuccessful hearing-aid users.
Data from a recent series of studies by N b lek and her colleagues (1991, 2004) indicate that successful and unsuccessful hearing-aids users can be predicted based on their performance on a subjective speech-in-noise task in which a most comfortable listening level is established for a travelogue story and the level of a multitalker babble is established that permits following the travelogue. The difference between these two levels is the acceptable noise level (ANL). Based on the ANL data, N b lek et al. (2006) report with 85% confidence those individuals who are successful hearing-aid users and those who are unsuccessful hearing-aid users. One premise of this proposal is that the ANL is in fact an estimate in the subjective realm of the signal-to-noise (S/N) at which the listener is comfortable listening to a speech signal in background noise.
Recently in our laboratory the words-in-noise (WIN) test was developed that involves the presentation of words in multitalker babble at signal-to-babble (S/B) ratios from 24- to 0-dB in 4-dB decrements. The 50% point on the function is calculated with the Spearman-K rber equation. This objective instrument provides an average 8-dB separation in recognition performances between listeners with normal hearing and listeners with hearing loss. The 50% points for the listeners with normal hearing are 0- and 6-dB S/B, whereas the 50% points for the listeners with hearing loss are 8- and 16-dB S/B. Thus, not only is the WIN very sensitive to the effects of hearing loss on speech understanding, but the WIN provides a range of performances by listeners with hearing loss.
The proposed study is designed to answer the following two key questions:
- What is the relationship between ANL performance (subjective paradigm) and WIN performance (objective paradigm) in both unaided and aided conditions?
- How well do the ANL and WIN scores predict subjective hearing-aid outcome domains (use, satisfaction, benefit, and global)?
In addition, the study design enables multiple comparisons to be made among several of the study variables and among many traditional variables such as age, pure-tone thresholds, and word-recognition abilities in quiet.
Future goals beyond this proposal involve the development (1) of systematic protocols to select amplification devices or specific features for amplification based on WIN or ANL performance, and (2) of audiologic rehabilitation programs that can be administered quickly and effectively (depending on the category of hearing-aid success that was determined from performances on the WIN or ANL) to veterans who are receiving hearing aids.
- Conditions
- Hearing Loss, Presbycusis
- Keywords
- hearing loss, hearing aids
- Medical subject headings
- Hearing Loss, Presbycusis
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 |
|---|---|---|
| hearing aid users | hearing aid users |
What is being measured
The primary outcome is the main question the study is designed to answer.
Words-in-noise Test
The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.
Measured: aided (after wearing hearing aids for at least 3 months)
Secondary outcomes (5)
Acceptable Noise Level Test
The ANL consists of a speech signal and a competing noise signal. The speech signal is a continuous monologue (Arizona Travelogue) by a male talker and the competing noise signal is the 12-talker babble from the Speech in Noise (SPIN) test (Kalikow et al, 1977). The speech and babble stimuli are recorded on separate channels on a compact disc (CD; Cosmos, Inc.). The task of the listener was to adjust the level of the travelogue to the most comfortable level (MCL) and then to adjust the level of the babble to the level the listener is willing "to put up with" and still follow the travelogue, or to the background noise level (BNL). The ANL (in dB) is the difference between the MCL and BNL.
Measured: aided (after wearing hearing aids for at least 3 months)
International Outcomes Inventory for Hearing Aids (IOI-HA)
Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.
Measured: aided (after wearing hearing aids for at least 3 months)
Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
Measures hearing-aid self-efficacy over four subscales (basic handling, advanced handling, adjustment, and aided listening). Subscale scores are averaged to produce a total self-efficacy scores that can range from 0 (low self-efficacy) to 100 (high self-efficacy).
Measured: aided (after wearing hearing aids for at least 3 months)
Satisfaction With Amplification in Daily Life (SADL)
Measures how satisfied listeners are with their current hearing aids. Total scale scores are computed by averaging the subscale (positive effect, negative features, personal image, and service \& delivery) scores that range from 1 (no satisfaction) to 7 (high satisfaction).
Measured: aided (after wearing hearing aids for at least 3 months)
Speech Spatial and Qualities of Hearing Scale (SSQ)
The SSQ measures hearing abilities related to speech, spatial perception, and quality of sound using a 1-10 scale. Items are averaged across the test. Higher scores indicate better outcomes.
Measured: aided (after wearing hearing aids for at least 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371449
- Sponsor's protocol ID
- C4352-R
- Status last verified
- Apr 2015
- First submitted
- 1 Sep 2006
- Last updated
- 29 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech-in-Noise Measures as a Predictor of Hearing Aid Outcomes
- ClinicalTrials.gov ID
- NCT00371449
- Acronym / sponsor ID
- C4352-R
- Conditions
- Hearing Loss, Presbycusis
- Keywords
- hearing loss, hearing aids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 2 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary complaint of individuals with hearing loss is difficulty understanding speech in the presence of background noise. Although hearing aids help individuals understand speech in background noise better, there is a high rate of hearing aid rejection in part due to continued difficulty understanding speech in complex listening situations. The results of this study may demonstrate that speech-in-noise test results can be a predictor of hearing aid success. The results of this study also may lead to further studies that can evaluate interventions to improve hearing aid success for individuals who are identified as unsuccessful hearing aid users.
Detailed description
As numerous studies have reported, the most common complaint that individuals with sensorineural hearing loss have about their hearing is that they can hear speech but they cannot understand speech, especially in background noise. For this type of hearing loss and most other types of hearing losses, hearing aids are the intervention of choice. The majority of individuals who receive hearing aids are successful hearing-aid users in that both subjectively and objectively they function better with their hearing aids than without hearing aids. Other individuals are unsuccessful hearing-aid users because for a variety of reasons their perception is that the hearing aids do not enable them to function better. Two studies (Popelka et al., 1998; Kockchin, 2000) indicate that about 25% of individuals who receive hearing aids can be considered unsuccessful hearing-aid users. If potentially (un)successful hearing-aid users can be identified, then audiologic rehabilitation programs can be designed for use with potentially successful hearing-aid users and more extensive audiologic rehabilitation programs can be designed for use with those individuals who are potentially unsuccessful hearing-aid users.
Data from a recent series of studies by N b lek and her colleagues (1991, 2004) indicate that successful and unsuccessful hearing-aids users can be predicted based on their performance on a subjective speech-in-noise task in which a most comfortable listening level is established for a travelogue story and the level of a multitalker babble is established that permits following the travelogue. The difference between these two levels is the acceptable noise level (ANL). Based on the ANL data, N b lek et al. (2006) report with 85% confidence those individuals who are successful hearing-aid users and those who are unsuccessful hearing-aid users. One premise of this proposal is that the ANL is in fact an estimate in the subjective realm of the signal-to-noise (S/N) at which the listener is comfortable listening to a speech signal in background noise.
Recently in our laboratory the words-in-noise (WIN) test was developed that involves the presentation of words in multitalker babble at signal-to-babble (S/B) ratios from 24- to 0-dB in 4-dB decrements. The 50% point on the function is calculated with the Spearman-K rber equation. This objective instrument provides an average 8-dB separation in recognition performances between listeners with normal hearing and listeners with hearing loss. The 50% points for the listeners with normal hearing are 0- and 6-dB S/B, whereas the 50% points for the listeners with hearing loss are 8- and 16-dB S/B. Thus, not only is the WIN very sensitive to the effects of hearing loss on speech understanding, but the WIN provides a range of performances by listeners with hearing loss.
The proposed study is designed to answer the following two key questions:
- What is the relationship between ANL performance (subjective paradigm) and WIN performance (objective paradigm) in both unaided and aided conditions?
- How well do the ANL and WIN scores predict subjective hearing-aid outcome domains (use, satisfaction, benefit, and global)?
In addition, the study design enables multiple comparisons to be made among several of the study variables and among many traditional variables such as age, pure-tone thresholds, and word-recognition abilities in quiet.
Future goals beyond this proposal involve the development (1) of systematic protocols to select amplification devices or specific features for amplification based on WIN or ANL performance, and (2) of audiologic rehabilitation programs that can be administered quickly and effectively (depending on the category of hearing-aid success that was determined from performances on the WIN or ANL) to veterans who are receiving hearing aids.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hearing aid users | – | –hearing aid users |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults with sensorineural hearing loss
Key inclusion criteria (5 listed)
- adult onset of hearing loss,
- symmetrical, sensorineural hearing loss,
- no more than 60 dB HL hearing loss measured via an average of air conduction thresholds at .5, 1, and 2 kHz in each ear, and
- use of binaural hearing aids of the same make and model for each ear
- at least 3 months of hearing aid use.
Key exclusion criteria (4 listed)
- enrollment in group audiologic rehabilitation classes,
- currently using an FM system,
- inability to read and write American English, and
- signs of middle ear or retrocochlear pathology.
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
Words-in-noise Test
Time frame: aided (after wearing hearing aids for at least 3 months)
The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.
5 secondary outcomes
Acceptable Noise Level Test
Time frame: aided (after wearing hearing aids for at least 3 months)
International Outcomes Inventory for Hearing Aids (IOI-HA)
Time frame: aided (after wearing hearing aids for at least 3 months)
Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
Time frame: aided (after wearing hearing aids for at least 3 months)
Satisfaction With Amplification in Daily Life (SADL)
Time frame: aided (after wearing hearing aids for at least 3 months)
Speech Spatial and Qualities of Hearing Scale (SSQ)
Time frame: aided (after wearing hearing aids for at least 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Loss and Presbycusis, run by US Department of Veterans Affairs 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 5 inclusion and 4 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 29 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Words-in-noise Test (time frame: aided (after wearing hearing aids for at least 3 months)). 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 29 Apr 2015.