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Not yet recruitingNCT07732920Updated Jul 29, 2026

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

An observational study in Conductive Hearing Loss and Sensorineural Hearing Loss, sponsored by Audioptics Medical Incorporated. Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Audioptics Medical Incorporated · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Conductive Hearing Loss
  • Sensorineural Hearing Loss

Keywords

  • OCT
  • vibrometry
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults ages 18+

Inclusion criteria

Adults ages 18+ Conductive or sensorineural hearing loss -

Exclusion criteria

Exclusion Criteria:

Adults with normal hearing Children Subjects unable to understand Informed consent

-

04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hearing loss

    Other: OCT - clear

Interventions

  • OtherOCT - clear

    OCT imaging and vibrometry

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What researchers measure

Primary outcomes

  1. Vibrometry (Ossicular mobility in mm/s/Pa)

    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

    Time frame: 2 years

  2. Standard audiometry--threshold measurement in dBHL

    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

    Time frame: 2 years

  3. Standard tympanometry--measurement of acoustic immittance in daPa

    Standard tympanometric testing of ear canal volume and middle ear immittance

    Time frame: 2 years

06

Study locations

2 sites
  • Zeiss Medical Technology/Audioptics Medical Incorporated
    Halifax, Nova Scotia B3J 0E9, Canada
    • Catherine Creaser · Contact · catherine.creaser@zeiss.com · 902-891-2891
    • Site Operations Manager · Contact · carmen.mcknight@zeiss.com · 902-440-2895
    • Catherine Creaser · Sub investigator
    • David P Morris, MD · Principal investigator
    • Rob Adamson · Sub investigator
  • CDHA, Nova Scotia Health Authority, 3039-5820 University Avenue 3rd floor Dickson Centre Halifax NS B3H 1V7 Canada
    Halifax, Nova Scotia, Canada
    • Catherine Creaser · Contact · catherine.creaser@zeiss.com · 902-891-2891
    • Site operations manager · Contact · carmen.mcknight@zeiss.com · 902-891-2891
    • David P Morris · Principal investigator
    • Catherine Creaser · Sub investigator
    • Rob Adamson, PhD · Sub investigator
07

References and documents

Publications

  • MacDougall D, Morrison L, Morrison C, Morris DP, Bance M, Adamson RBA. Optical Coherence Tomography Doppler Vibrometry Measurement of Stapes Vibration in Patients With Stapes Fixation and Normal Controls. Otol Neurotol. 2019 Apr;40(4):e349-e355. doi: 10.1097/MAO.0000000000002193. PubMed 30870352 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT07732920
Lead sponsor
Audioptics Medical Incorporated
Collaborators
Nova Scotia Health Authority, Dalhousie University
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Jul 29, 2026

Study contacts

Catherine L Creaser
Contact
catherine.creaser@zeiss.com
902-891-2891
Site operations manager
Contact
carmen.mcknight@zeiss.com
902-440-2895
David P Morris, MD
principal investigator · Nova Scotia Health Authority

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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