View clinical trials related to Hearing Loss, Conductive.
Filter by:Conductive hearing loss is very common and the incidence increases with age. Until now, the scanner was the reference examination in the etiological diagnosis of deafness. When performing a CT scan of temporal bones for the etiological diagnosis of conductive hearing loss, the quality of the image depends on the scanner brand and the acquisition parameters. The investigators wish to show the usefulness of the cone beam in the diagnosis of conductive hearing loss
Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D/HH children, reducing the likelihood of speech and language delays. A diverse group of 28,000 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results. In addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D/HH children.
The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria). The BB augments hearing by providing acoustic input to the inner ear via bone conduction. In 2017 Hodgetts & Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated. The aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.
Background: The Eustachian Tube (ET) is a mucosa-lined connection between the nasopharynx and the middle ear cavity. It is believed to have three functions: 1) ventilation of and pressure equalization in the middle ear cavity, 2) mucus drainage from the middle ear, and 3) protection against sound and infection from the nasopharynx1. In adults, Eustachian Tube Dysfunction (ETD) can cause complaints from one or both ears. For many years, various definitions of ETD have been used, impairing the opportunity to compare studies. However, in 2015, an international consensus on definition, types, clinical presentation, and diagnosis of ETD was published by Schilder et al2, which has been adopted by all the Scandinavian countries. The symptoms include pressure (fullness), and/or pain in the ear, muffled hearing, and overall discomfort. Furthermore, chronic ETD can result in tympanic membrane retraction, atelectasis of the middle ear cavity, and ultimately formation of cholesteatoma3. Unfortunately, the symptoms of ETD are multiple and inaccurate giving rise to varying estimates of the prevalence. As an example, a study in UK found a 0.9 % prevalence of ETD4. In addition, clear guidelines on diagnostics and treatment are not currently available due to the fact, that no objective test for detection of ETD exists. In the need of a symptom scoring system, the patient reported Eustachian Tube Dysfunction Questionnaire (ETDQ-7) has been developed and validated in English5. Yet, translation into other languages as well as validation in other settings are necessary in order to substantiate the applicability of ETDQ-7. ETD is associated with a lack of opening of ET. It is believed that the length, diameter and angle of ET influences its ability to open regularly, thus affecting its function. A short, narrow and angled ET may predispose to ETD. However, the imaging available to visualize ET are not accurate enough to diagnose ETD. A direct test of the function of ET is not available. Tubomanometry is a relatively new method developed to directly test the opening of ET, but is yet to be validated6. Both non-surgical and surgical treatment options to improve the function of the Eustachian Tube are available. Non-surgical management includes pressure equalization methods (e.g. the Valsalva maneuver), antihistamines, treatment with decongestants, and nasal douching with a saline solution. Surgically, ventilation tubes are often used to treat ETD. In case of adenoid hypertrophy obstructing the pharyngeal opening of ET, adenoidectomy is recommended. Balloon Eustachian Tuboplasty (BET) was introduced in 2010 by Ockermann et al7. BET is a non-invasive procedure performed under general anesthesia. During the procedure, a catheter is inserted either endonasally or transtympanic into ET, and a balloon is inflated with water for approximately two minutes. Various heterogeneous studies have shown a short-term effect of BET, but long-term effects are unclear8. In summary, despite the assumption of being a common condition, the field of ETD suffers from lack of precise definition, diagnostic criteria, identification of underlying causes as well as purposeful treatment, and prognostic factors. Especially, long-term effects of BET need further investigation. Therefore, in an effort to fill out the gap of knowledge about ETD, the following specific aims are proposed:
The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits. The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study. Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016. The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower. The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has several advantages since it avoids a second surgical procedure. The single-stage approach is proven to be safe and feasible in adults and is nowadays referred to as the standard surgical technique in adults. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT) surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has several advantages since it avoids a second surgical procedure. The single-stage approach is proven to be safe and feasible in adults and is nowadays referred to as the standard surgical technique in adults. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT)-surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.