The Anatomic Determinants of Perforation Induced Hearing Loss

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Brief Title

The Anatomic Determinants of Perforation Induced Hearing Loss

Official Title

The Anatomic Determinants of Perforation Induced Hearing Loss

Brief Summary

      The purpose of this study is to identify factors that may contribute to conductive hearing
      loss. Conductive hearing loss is a type that is due to a problem with the outer or middle
      ear. Because of this, sound does not travel through the ear normally. Perforated tympanic
      membranes of study patients will be photographed during the patient's routine visit using a
      digital otoscope. These pictures will be used to analyze perforation size as an absolute
      value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of
      temporal bone (reports and images) collected as standard of care will be evaluated. Images of
      CT scans will be imported into a medical imaging software for creation of anatomically
      realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D
      model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be
      recorded, and data points will be correlated with perforation size and location to audiogram

Study Type


Primary Outcome

presence of perforation


Conductive Hearing Loss

Study Arms / Comparison Groups

 Patients with conductive hearing loss


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

April 2017

Completion Date

January 3, 2018

Primary Completion Date

January 3, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Between 18 and 89 years of age

          -  Confirmed diagnosis of conductive hearing loss secondary to tympanic membrane

          -  Treated for the above condition by a Duke physician

          -  Received both a CT temporal bone scan interpreted by a Duke radiologist and audiometry
             at a Duke-based facility (both tests performed within four weeks of each other), as
             part of standard pre-operative workup

        Exclusion Criteria:

          -  Temporal CT scan with inadequate resolution as per determination of study staff

          -  Unable to provide written informed consent

          -  Unable to read and understand English




18 Years - 89 Years

Accepts Healthy Volunteers



Dennis Frank-Ito, PhD, , 

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Duke University

Study Sponsor

Dennis Frank-Ito, PhD, Principal Investigator, Duke University

Verification Date

January 2018