Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371449
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2006-09-01
Brief Title:
Predicting Success With Hearing Aids
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Speech-in-Noise Measures as a Predictor of Hearing Aid Outcomes
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 unsuccessful 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 SN 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 SB 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 SB whereas the 50 points for the listeners with hearing loss are 8- and 16-dB SB 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
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 SN 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 SB 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 SB whereas the 50 points for the listeners with hearing loss are 8- and 16-dB SB 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None