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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07732920
Enrollment
500
Registered
2026-07-29
Start date
2026-08-01
Completion date
2028-08-31
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conductive Hearing Loss, Sensorineural Hearing Loss

Keywords

OCT, vibrometry

Brief 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.

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.

Interventions

OCT imaging and vibrometry

Sponsors

Audioptics Medical Incorporated
Lead SponsorINDUSTRY
Nova Scotia Health Authority
CollaboratorOTHER
Dalhousie University
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults ages 18+ Conductive or sensorineural hearing loss -

Exclusion criteria

Adults with normal hearing Children Subjects unable to understand Informed consent \-

Design outcomes

Primary

MeasureTime frameDescription
Vibrometry (Ossicular mobility in mm/s/Pa)2 yearsOptical 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
Standard audiometry--threshold measurement in dBHL2 yearsStandard 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
Standard tympanometry--measurement of acoustic immittance in daPa2 yearsStandard tympanometric testing of ear canal volume and middle ear immittance

Countries

Canada

Contacts

CONTACTCatherine L Creaser
catherine.creaser@zeiss.com902-891-2891
CONTACTSite operations manager
carmen.mcknight@zeiss.com902-440-2895
PRINCIPAL_INVESTIGATORDavid P Morris, MD

Nova Scotia Health Authority

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026