Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively (PalpEar)

Sensoptic SA

Status

Completed

Conditions

Cholesteatoma, Middle Ear

Otosclerosis of Middle Ear

Disorder of Middle Ear

Treatments

Device: PalpEar

Study type

Interventional

Funder types

Industry

Identifiers

NCT02554422

2013-MD-0014

Details and patient eligibility

About

Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).

Full description

The aim of this study was to develop and test a palpating instrument, which enables the experienced and occasional otologic surgeon to record force in three dimensions during his standard palpation of each ossicle at surgery and al-lows correlation of his subjective impression with objective measurement results. The first task was to incorporate force sensing capability into a standard 45° angulated 2.5 mm hook, which is commonly used to palpate, disconnect and luxate ossicles during middle ear surgery.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult subjects
Normally scheduled for middle-ear or internal-ear surgery as a result of an ear disease and for whom a routine assessment of the mobility of the ossicle chain is in order.

The targeted subject population consists of patients undergoing stapedotomy for otosclerosis and subjects with a normal ossicular chain who are subject to the placement of a cochlear implant to treat hearing loss.

Exclusion criteria