NCT01781039

Brief Summary

Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6.9 years

First QC Date

January 29, 2013

Last Update Submit

March 10, 2026

Conditions

Keywords

"hair cell""hearing aid""hearing loss""auditory nerve"synaptopathy"Outer hair cell""Otoacoustic emission"

Outcome Measures

Primary Outcomes (1)

  • Regression analysis

    Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.

    June 2024

Study Arms (7)

low HIN difficulty- anesthetized

Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans

high HIN difficulty- anesthetized

Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans

Hearing Aid fitting: MAD

Microphone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized

Device: Hearing Aid fitting

Hearing Aid fitting: WDC

Wide dynamic compression (WDC) feature will be set to target levels, the MAD feature set to omnidirectional, and the DNR minimized.

Device: Hearing Aid fitting

Hearing Aid fitting: DNR

Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear

Device: Hearing Aid fitting

Hearing Aid fitting: Positive control

All hearing aid features enables

Device: Hearing Aid fitting

Hearing Aid fitting: Negative control

All hearing aid features disabled

Device: Hearing Aid fitting

Interventions

Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.

Hearing Aid fitting: DNRHearing Aid fitting: MADHearing Aid fitting: Negative controlHearing Aid fitting: Positive controlHearing Aid fitting: WDC

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients referred from the St. Elizabeth's Department of Otolaryngology and self-referred patients to the Audiology Clinic.

You may qualify if:

  • Normal hearing to moderate sensorineural hearing loss
  • Sufficient English proficiency to complete speech discrimination testing in English

You may not qualify if:

  • Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)
  • Conductive hearing loss
  • Neurodegenerative disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Related Publications (3)

  • Bramhall N, Ong B, Ko J, Parker M. Speech Perception Ability in Noise is Correlated with Auditory Brainstem Response Wave I Amplitude. J Am Acad Audiol. 2015 May;26(5):509-517. doi: 10.3766/jaaa.14100.

  • Hoben R, Easow G, Pevzner S, Parker MA. Outer Hair Cell and Auditory Nerve Function in Speech Recognition in Quiet and in Background Noise. Front Neurosci. 2017 Apr 7;11:157. doi: 10.3389/fnins.2017.00157. eCollection 2017.

  • Parker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24.

Related Links

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing LossVestibulocochlear Nerve Diseases

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRetrocochlear DiseasesCranial Nerve Diseases

Study Officials

  • Mark Parker, PhD

    Steward St. Elizabeth's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations