Predicting Success With Hearing Aids

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00371449
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Duration (Months): 31
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss; Presbycusis

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:

1. What is the relationship between ANL performance (subjective paradigm) and WIN performance (objective paradigm) in both unaided and aided conditions?

2. 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

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Speech-in-Noise Measures as a Predictor of Hearing Aid Outcomes
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
hearing aid users hearing aid users

Outcome Measures

Primary Outcome Measures

1. Words-in-noise Test [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.

Secondary Outcome Measures

1. Acceptable Noise Level Test [aided (after wearing hearing aids for at least 3 months)]

   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.

2. International Outcomes Inventory for Hearing Aids (IOI-HA) [aided (after wearing hearing aids for at least 3 months)]

   Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.

3. Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) [aided (after wearing hearing aids for at least 3 months)]

   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).

4. Satisfaction With Amplification in Daily Life (SADL) [aided (after wearing hearing aids for at least 3 months)]

   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).

5. Speech Spatial and Qualities of Hearing Scale (SSQ) [aided (after wearing hearing aids for at least 3 months)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James H. Quillen VA Medical Center	Mountain Home	Tennessee	United States	37684

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00371449
• Other Study ID Numbers: C4352-R
• First Posted: Sep 4, 2006
• Last Update Posted: Apr 29, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by US Department of Veterans Affairs: hearing loss; hearing aids
• Additional relevant MeSH terms: Hearing Loss; Deafness; Presbycusis

Study Results

Participant Flow

Arm/Group Title	Hearing-Aid Users
Arm/Group Description	Individuals who wore hearing aids for > 3 months and at their current setting for at least 1 month
Period Title: Overall Study
STARTED	120
COMPLETED	120
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hearing Aid Users
Arm/Group Description	Hearing aid users
Overall Participants	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.4 (8.2)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	120 100%
degree of hearing loss (dB HL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [dB HL]	36.3 (10.8)
unaided Words-In-Noise Test (dB S/N) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [dB S/N]	14.4 (4.5)
unaided Acceptable Noise Level test (dB) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [dB]	15.5 (7.2)

Outcome Measures

1. Primary Outcome

Title	Words-in-noise Test
Description	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.
Time Frame	aided (after wearing hearing aids for at least 3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	hearing aid users
Measure Participants	120
Mean (Standard Deviation) [dB S/N]	12.6 (3.7)

2. Secondary Outcome

Title	Acceptable Noise Level Test
Description	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.
Time Frame	aided (after wearing hearing aids for at least 3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hearing-aid Users
Arm/Group Description	hearing aid users
Measure Participants	120
Mean (Standard Deviation) [dB]	13.5 (6.8)

3. Secondary Outcome

Title	International Outcomes Inventory for Hearing Aids (IOI-HA)
Description	Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.
Time Frame	aided (after wearing hearing aids for at least 3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hearing Aid Users
Arm/Group Description	hearing aid users
Measure Participants	120
Mean (Standard Deviation) [units on a scale (points)]	28.9 (3.8)

4. Secondary Outcome

Title	Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
Description	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).
Time Frame	aided (after wearing hearing aids for at least 3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hearing Aid Users
Arm/Group Description	hearing aid users
Measure Participants	120
Mean (Standard Deviation) [% level of self-efficacy]	84.7 (9.4)

5. Secondary Outcome

Title	Satisfaction With Amplification in Daily Life (SADL)
Description	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).
Time Frame	aided (after wearing hearing aids for at least 3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hearing Aid Users
Arm/Group Description	hearing aid users
Measure Participants	120
Mean (Standard Deviation) [units on a scale (points)]	5.4 (0.7)

6. Secondary Outcome

Title	Speech Spatial and Qualities of Hearing Scale (SSQ)
Description	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.
Time Frame	aided (after wearing hearing aids for at least 3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hearing Aid Users
Arm/Group Description	hearing aid users
Measure Participants	120
Mean (Standard Deviation) [units on a scale (points)]	7.2 (1.4)

Adverse Events

Arm/Group Title	Hearing-aid Users
Arm/Group Description
All Cause Mortality
	Hearing-aid Users
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hearing-aid Users
	Affected / at Risk (%)	# Events
Total	0/120 (0%)
Other (Not Including Serious) Adverse Events
	Hearing-aid Users
	Affected / at Risk (%)	# Events
Total	0/120 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.