Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss

July 27, 2026 updated by: Audioptics Medical Incorporated

OCT Imaging and Vibrometry in Patients With Hearing Loss: A Pilot Study

This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an exploratory clinical investigation to obtain pilot imaging and vibrometry data in patients with various hearing loss aetiologies and to identify qualitative and quantitative features associated with specific pathologies. The data collected in this study is intended to support future investigations into the accuracy of the system in diagnosing specific middle ear disorders.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 0E9
        • Zeiss Medical Technology/Audioptics Medical Incorporated
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Catherine Creaser
        • Principal Investigator:
          • David P Morris, MD
        • Sub-Investigator:
          • Rob Adamson
      • Halifax, Nova Scotia, Canada
        • CDHA, Nova Scotia Health Authority, 3039-5820 University Avenue 3rd floor Dickson Centre Halifax NS B3H 1V7 Canada
        • Contact:
        • Sub-Investigator:
          • Catherine Creaser
        • Contact:
        • Principal Investigator:
          • David P Morris
        • Sub-Investigator:
          • Rob Adamson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults ages 18+

Description

Inclusion Criteria:

Adults ages 18+ Conductive or sensorineural hearing loss -

Exclusion Criteria:

Adults with normal hearing Children Subjects unable to understand Informed consent

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hearing loss
Other: OCT - clear
OCT imaging and vibrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vibrometry (Ossicular mobility in mm/s/Pa)
Time Frame: 2 years
Optical Coherenece Tomography vibrometry measures of ossicular mobility for the umbo and incus in mm/s/Pa for 6 frequencies of 500, 750, 1000, 1500, 2000 and 3000 Hz
2 years
Standard audiometry--threshold measurement in dBHL
Time Frame: 2 years
Standard pure tone and bone conduction audiometry--measurement of acoustic thresholds for air and bone conductive stimuli at 250, 500, 1000, 2000, 3000 , 4000, 6000 and 8000 Hz
2 years
Standard tympanometry--measurement of acoustic immittance in daPa
Time Frame: 2 years
Standard tympanometric testing of ear canal volume and middle ear immittance
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Audioptics Medical Incorporated

Collaborators

Nova Scotia Health Authority
Dalhousie University

Investigators

  • Principal Investigator: David P Morris, MD, Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-1868

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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