Restoration of Spectral Resolution With Hearing-aid Amplification

Not Applicable

Completed

Conditions: Hearing Loss

Interventions: Device: Hearing Aid

Registration Number: NCT03850678

Lead Sponsor: University of Nebraska Lincoln

Brief Summary: The objective of this study protocol is to determine the efficacy of using aided measures of spectral resolution to set the dynamic range of hearing with hearing-aid amplification. Measures of spectral resolution will be obtained, as will measures of speech recognition.

Detailed Description: Adults with hearing loss are more vulnerable to interference from background noise than adults with normal hearing. Despite the fact that the ability to extract speech information imbedded in background noise requires decoding differences in level across frequency (spectral information), few studies have addressed the extent to which spectral information can be provided to listeners with hearing loss. This fundamental gap in our knowledge prevents society from effectively addressing the systemic effects of hearing loss on communication, income, and ability to socialize with others. This work is a new application of established methods of characterizing spectral resolution to that of the most common device for rehabilitation of hearing loss, hearing-aid amplification. Because hearing aids do not require premarket approval, FDA oversight is not applicable to this clinical trial.

The experiments will examine the degree to which access to spectral information can be restored to adults with hearing loss and the feasibility of utilizing this information to decrease interference from background noise. Aim 1 will delineate the impact of hearing-aid amplification on spectral decoding. Technology options that must be set by the clinician or hearing-aid manufacturer will be examined, including the frequency-specific gain, compressor speed, and number of compression channels. The proposed experiments will test the hypothesis that restoration of the lost dynamic range of hearing can support the encoding of spectral information. It is also hypothesized that the combination of technology options that best restore access to spectral information will differ across individuals and that these differences across individuals can be partially accounted for by an estimate of outer hair cell function. Aim 2 will determine the extent to which restoring access to spectral information supports speech recognition in background noise, under the guiding hypothesis that improving spectral resolution increases speech understanding. If it can be demonstrated that measures of spectral resolution with the provision of amplification are useful at delineating those who stand to benefit from different technology options, the knowledge gained could then be applied to the clinic to allow for clinicians to more successfully choose among different rehabilitation options.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 209

Inclusion Criteria

normal tympanograms (peak admittance of ≥ 0.2 mmhos, -200 to 50); Hearing thresholds for normal hearing group less than or equal to 20 decibels in hearing level (dB HL) from .25 to 8 kHz. Pure-tone average (2, 4 & 6 kHz) hearing thresholds for participants with hearing loss of 30 - 65 dB HL.

Exclusion Criteria

cognitive impairment

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Hearing Aid	Hearing Aid	Group of participants with hearing loss. Subjects will complete a questionnaire that asks relevant questions about their medical and developmental history and educational level. Participants will be screened for a potential cognitive impairment using the Montreal Cognitive Assessment Basic (MOCA-B). Working memory span will be assessed using the reading span test. Each subject will undergo a routine audiological examination, including audiometric testing and tympanometry. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels, while manipulating different hearing aid parameters and also without the provision of amplification, will be assessed.

Primary Outcome Measures

Name	Time	Method
Spectral Resolution	Each test was approximately 10 minutes and was completed after each experimental manipulation	Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit.
Speech Recognition	Each test was approximately 10 minutes and was completed after each experimental manipulation	measure of spatial release from masking (dB) for a masker presented at 70 dB SPL.

Secondary Outcome Measures

Name	Time	Method
Working Memory	Each test was approximately 30 minutes and was completed only once per subject.	Measure of working memory (correctly repeated words from the reading span test). The minimum (poorer) and maximum (better) values are 0 and 57, respectively.