CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Hearing aids programmed conventionally. +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04145661
NCT04145661N/ACompleted

A Comparison of Conventional Hearing Aid Processing (CP) and Non-linear Frequency Compression (NLFC) Processing in Adult Patients With and Without Cochlear Dead Regions Who Have a Moderate to Severe Sensorineural Hearing Loss.

Manchester University NHS Foundation Trust·interventional·Posted Oct 30, 2019·Updated Jun 1, 2020

In Brief

A clinical study evaluating Hearing aids programmed conventionally. and Hearing aids programmed with compression activated. for Sensorineural Hearing Loss, Bilateral and Cochlear Hearing Loss. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The investigators are interested in an additional hearing aid feature called non-linear frequency compression (NLFC). This aims to improve audibility of high frequency sounds by converting them into lower frequencies and has been shown to benefit those with moderate-severe sensorineural hearing loss (SNHL). Cochlear dead regions (DRs) are areas of the inner hearing organ (the cochlea) where there is little or no function and are commonly found in regions responsible for detecting high pitched (frequency) sounds. Not all people with hearing loss have DRs. The investigators would like to determine whether based on the presence or absence of DRs, patients with moderate-severe SNHL perform better or prefer their hearing aids programmed conventionally, or with NLFC activated. To do this, two participant groups will be created based on findings from the threshold equalising noise (TEN) test which identifies cochlear DRs. Two participant groups will be created; one group with DRs and one group without DRs. All participants will receive two hearing aids and will wear these programmed conventionally for \~six weeks and with NLFC activated for \~six weeks in a counterbalanced manner. Following each condition, participants will complete a questionnaire and various speech tests will be performed. This involves participants repeating sentences, words or speech sounds they hear from a speaker in quiet and in the presence of background noise. Individuals' scores will be calculated for each test and their performance when NLFC was activated and deactivated will be compared. This will be analysed alongside the questionnaire data to compare the 'DR' and 'no DR' group in both conditions. Findings may help to determine whether NLFC should be activated for all moderate-severe SNHL patients, or just those with DRs, helping clinicians to optimise hearing aid settings for patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 30, 2019
Enrollment StartNov 20, 2019
Primary CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.7 years ago

Interventions

Hearing aids programmed conventionally.device

All participants will wear their hearing aids programmed in this way for around six weeks.

Hearing aids programmed with compression activated.device

All participants will wear their hearing aids programmed in this way for around six weeks.