View clinical trials related to Hearing Loss, Conductive.
Filter by:Main objectives - The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain. - The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort. Secondary objectives - Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband. - Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband. - Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband. - Evaluate the satisfaction and use of ADHEAR.
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 results.
A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear. Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients. Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.