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Predicting Success With Hearing Aids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00371449
First received: September 1, 2006
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

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
Hearing Loss
Presbycusis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Speech-in-Noise Measures as a Predictor of Hearing Aid Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • words-in-noise test [ Time Frame: uniaded/aided ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptable Noise Level Test [ Time Frame: pre-post ] [ Designated as safety issue: No ]
  • International Outcomes Inventory for Hearing Aids (IOI-HA) [ Time Frame: aided ] [ Designated as safety issue: No ]
  • Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) [ Time Frame: aided ] [ Designated as safety issue: No ]
  • Satisfaction with Amplification in Daily Life (SADL) [ Time Frame: aided ] [ Designated as safety issue: No ]
  • Speech Spatial and Qualities of Hearing Scale (SSQ) [ Time Frame: aided ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 2006
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
successful hearing aid users
Group 2
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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adults with sensorineural hearing loss

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371449

Locations
United States, Tennessee
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00371449     History of Changes
Other Study ID Numbers: C4352-R
Study First Received: September 1, 2006
Last Updated: November 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
comparison
group study

Additional relevant MeSH terms:
Deafness
Hearing Loss
Presbycusis
Ear Diseases
Hearing Disorders
Hearing Loss, Sensorineural
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014