Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing

Summary

The Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Eustachian tube dysfunction (ETD) can result in pain or a popping sensation in the ears when flying in an airplane or going up a tall building in an elevator. Many people with ETD also suffer from ear problems such as repeated middle-ear infections or fluid in the ears. However, there are very few easily-administered tests to measure and assess Eustachian tube function (ETF). Tubomanometry is one of these tests, however it is expensive and used to measure ETF only in research settings. In this study, the investigators propose that using a combination of two readily available devices, the EarPopper and a tympanometer, will work in a manner similar to a Tubomanometer to test ET function.

Conditions

• Eustachian Tube Dysfunction

Interventions

DEVICE

EarPopper

The EarPopper is 510(K) regulated (510(K) Number K073401) and is marketed as a safe and effective way to aid muscle-assisted ET opening. It is a Politzer device, and aids ET opening by blowing a constant stream of air into the nasal cavity. It consists of a single nose piece connected to an air pump with no adjustable pressure settings. During the study, the subject will be asked to place the nose piece into one of the nostrils while occluding the contralateral. The subject will then perform the maneuvers (swallow, "Fish", blowing out into the EMST-150).

DEVICE

Tympanometry

The Tympanometer is 510(K) regulated (510(K) Number K083861) and is marketed as a way to measure auditory impedance and acoustics reflex by producing controlled levels of test tones and signals. It will be used before and after each maneuver for both the EarPopper and Tubomanometry tests to assess middle ear pressure change.

DEVICE

Tubomanometry

Tubomanometry is an established test of Eustachian tube function. It is an easily-administered test used in clinical laboratories. It consists of a nosepiece and an ear canal pressure probe coupled to a manometer and air pump. When the nosepiece and ear canal probe is in place, a maneuver, such as swallowing, will cause the tubomanometer to generate a bolus of air at 30, 40, or 50 mbar through the nosepiece. In the event that the Eustachian tube opens, the tympanic membrane will be displaced, which in turn will be sensed by the ear probe. This event will be recorded as a Eustachian tube opening. For this test, the investigators will ask the subject to perform the maneuvers (swallow, "Fish", blowing out into the EMST-150).

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• University of Pittsburgh

  collaborator OTHER

• Cuneyt M. Alper

  lead OTHER

Principal Investigators

• Cuneyt M Alper, MD · University of Pittsburgh

Eligibility

Min Age

5 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-27

Primary Completion

2019-11-18

Completion

2019-11-18

FDA Device

Yes

Countries

• United States

Study Locations