Sensorineural Hearing LossNCT01781039
Investigation of Anatomical Correlates of Speech Discrimination
An observational study of Sensorineural Hearing Loss, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Hearing Aid fitting
- Type of treatment
- Medical device
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients referred from the St. Elizabeth's Department of Otolaryngology and self-referred patients to the Audiology Clinic.
Who may be able to join
- Normal hearing to moderate sensorineural hearing loss
- Sufficient English proficiency to complete speech discrimination testing in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
About this study
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.
Read the detailed description
Patients receiving routine audiologic evaluations who meet study criteria will be asked to participate in the study. Study participants will receive an ABR and DPOAE evaluation and speech-in-noise testing. Participants who are hearing aid candidates will be fit with loaner hearing aids with noise reduction technology for 2 weeks. Wave 1 amplitudes from the ABR, DPOAE levels, speech discrimination scores, unaided and aided speech0in-noise performance age, and pure tone thresholds will be recorded, as well as any audiologic diagnosis that may confound the results.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Hearing Aid fitting
- Keywords
- "hair cell", "hearing aid", "hearing loss", "auditory nerve", synaptopathy, "Outer hair cell", "Otoacoustic emission"
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Vestibulocochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid fittingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Hearing Aid fitting | |
| Hearing Aid fitting: DNR | Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear Receives: Device: Hearing Aid fitting | |
| Hearing Aid fitting: Positive control | All hearing aid features enables Receives: Device: Hearing Aid fitting | |
| Hearing Aid fitting: Negative control | All hearing aid features disabled Receives: Device: Hearing Aid fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study start1 Jan 2013
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Parker, PhD, Principal investigator, Steward St. Elizabeth's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781039
- Sponsor's protocol ID
- 00652
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2013
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26055840Hoben 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.
PubMed 28439223Parker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24.
PubMed 33011456
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Anatomical Correlates of Speech Discrimination
- ClinicalTrials.gov ID
- NCT01781039
- Acronym / sponsor ID
- 00652
- Conditions
- Sensorineural Hearing Loss
- Keywords
- "hair cell", "hearing aid", "hearing loss", "auditory nerve", synaptopathy, "Outer hair cell", "Otoacoustic emission"
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients receiving routine audiologic evaluations who meet study criteria will be asked to participate in the study. Study participants will receive an ABR and DPOAE evaluation and speech-in-noise testing. Participants who are hearing aid candidates will be fit with loaner hearing aids with noise reduction technology for 2 weeks. Wave 1 amplitudes from the ABR, DPOAE levels, speech discrimination scores, unaided and aided speech0in-noise performance age, and pure tone thresholds will be recorded, as well as any audiologic diagnosis that may confound the results.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Hearing Aid fittingMicrophone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized |
| Hearing Aid fitting: WDC | – | Device: Hearing Aid fittingWide dynamic compression (WDC) feature will be set to target levels, the MAD feature set to omnidirectional, and the DNR minimized. |
| Hearing Aid fitting: DNR | – | Device: Hearing Aid fittingDigital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear |
| Hearing Aid fitting: Positive control | – | Device: Hearing Aid fittingAll hearing aid features enables |
| Hearing Aid fitting: Negative control | – | Device: Hearing Aid fittingAll hearing aid features disabled |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred from the St. Elizabeth's Department of Otolaryngology and self-referred patients to the Audiology Clinic.
Key inclusion criteria (2 listed)
- Normal hearing to moderate sensorineural hearing loss
- Sufficient English proficiency to complete speech discrimination testing in English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aid fittingSubjects 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. | Device | Hearing Aid fitting: DNR, Hearing Aid fitting: MAD, Hearing Aid fitting: Negative control, Hearing Aid fitting: Positive control, Hearing Aid fitting: WDC |
Primary outcome
Regression analysis
Time frame: June 2024
Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 26055840Bramhall 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.
- Results publication: PubMed 28439223Hoben 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.
- Results publication: PubMed 33011456Parker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24.
- Peer reviewed publicationLink provided by the sponsor.
- Peer reviewed publicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Parker, PhD principal investigator
Steward St. Elizabeth's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression analysis (time frame: June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781039, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.