Clinical Research Directory

Effectiveness of Speech Therapy for Lip-reading in Patients With Hearing Aids: SCED Study

This study aims to investigate whether lip reading rehabilitation improves viseme recognition in individuals with hearing impairments who use hearing aids.

The Performance of Different Sound Paths in Adult NeuroZti CI-users

The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant. Following Cochlear's acquisition of Neurelec, there is a need to support existing NeuroZti implant users who currently rely on the Neuro 2 sound processor. The Nuc8-based sound processor, currently in development, is designed to be compatible with the Neuro system while integrating with Cochlear's ecosystem of tools and applications developed over the past decade. To ensure long-term support and maintainability, transitioning to the Nuc8 sound path is preferred. However, changes in sound paths may impact sound quality, speech perception, and user acceptance. The main question this study aims to answer is: how does speech performance and user satisfaction compare between the Nuc8 and Neu2 sound paths? Participants will: * Undergo speech perception testing in quiet environments * Provide ratings on comfort and overall satisfaction The study involves a single visit lasting approximately 3 hours.

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts. This study will explore new ways to process the sound from the implanted microphone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.

Sentio Systematic Evaluation

The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.

Hearing Screening in Adults Over 50 Years Old

The goal of this single-arm quasi-experimental study is to evaluate the feasibility, effectiveness, and management of three different hearing screening methods in adults aged 50 years and older in the Czech Republic. The main questions it aims to answer are: Are the selected hearing screening methods effective in detecting hearing loss in the target population? Can these methods be successfully implemented within the national healthcare system to address gaps in current practices? Participants will: 1. Undergo hearing screening using all three methods, conducted by general practitioners, to assess their performance. 2. Complete follow-up evaluations conducted by ENT specialists to confirm diagnostic results.

How Parents, Children, and Clinicians Experience Digital Health Tools in Pediatric Audiology

The goal of this observational study is to understand how children with hearing loss, their parents, and health care providers experience digital health questionnaires that are completed before audiology follow-up appointments. The study focuses on children and adolescents (aged 7-18 years old) with hearing loss, and their parents, visiting the Audiology outpatient clinic of the Erasmus MC Sophia Children's Hospital. The main questions it aims to answer are: * How do parents, children, and clinicians experience digital questionnaires like the HEAR-QL before an audiology visit? * Do these digital tools help improve communication and preparation for the appointment? Participants will: * Be invited to complete a short feedback questionnaire about their experience with digital tools * Share their views on how helpful or relevant the questionnaires were * Health care providers will also give feedback on how they use and interpret the responses in clinical care

Reliability of a Portable Audiometric Device Based on Active Noise-Canceling Headphones for Clinical Hearing Assessment

Part One: Research Background Globally, approximately 500 million people suffer from disabling hearing loss, accounting for about 6.8% of the world's population. Hearing loss has emerged as a major global health issue. The cornerstone of hearing loss prevention and protection lies in hearing level testing. Early detection and intervention are crucial components of hearing healthcare. Currently, pure tone audiometry serves as the gold standard for hearing level testing, requiring patients to visit a hospital's standard soundproof room and complete the test under the guidance of a professional audiologist. However, existing professional audiometers are bulky, consume high power, and necessitate soundproof rooms (with background noise \<30dBA), among other drawbacks. Moreover, primary hospitals or units lack professional audiologists and soundproof rooms, making it impossible to diagnose and treat hearing loss. Therefore, a portable hearing testing device that does not require a soundproof room would be a boon for the diagnosis and treatment of hearing loss patients. Currently, Wuhan Douting Technology Co., Ltd. has produced a portable hearing testing device (E200), supporting frequencies from 125Hz to 16000Hz, covering both conventional and extended high frequencies. The frequency tolerance, total harmonic distortion, and accuracy of hearing levels fully meet the technical requirements of Grade 4 audiometers according to national standards. In addition to meeting the functional and performance requirements of general audiometers, this device offers the following technical advantages and innovations: 1. Combining active and passive noise reduction, it achieves comprehensive noise reduction of over 29dBSPL, allowing for audiometry in environments with background noise \<60dBA; 2. Supporting extended high frequencies, it can detect potential hearing damage earlier; 3. Supporting audiometry for rapid use by non-professionals, with automatic calibration, allowing non-professionals to operate by following prompts. This device is not yet on the market, and we intend to verify its reliability in assessing hearing conditions. Part Two: Research Objectives To verify the reliability of a novel portable hearing testing device in assessing hearing conditions. Part Three: Research Design Paired design Part Four: Inclusion and Exclusion Criteria Inclusion Criteria: Age: ≥6 years old, no gender restriction Able to cooperate in completing pure tone audiometry Exclusion Criteria: Patients with acute otitis media or unremovable secretions blocking the external auditory canal Patients with mental or psychological disorders or unable to cooperate with the examination for other reasons Part Five: Research Process This study will recruit volunteers from the outpatient and inpatient departments of Xijing Hospital. Each volunteer will undergo two audiological tests, with at least a 10-minute interval between the two tests to prevent intolerance to the hearing tests. Each audiological test will take approximately 6-8 minutes per subject. Consultation and Physical Examination: Researchers will collect general information, including name, gender, age, hearing status, and ear disease history; Conduct a physical examination of the ears; If a volunteer meets the inclusion criteria and voluntarily sign the informed consent form, researchers will determine the testing order using a random number method based on your enrollment sequence. Conventional pure-tone audiometry:Patients undergo conventional pure tone audiometry using the interacoustics AC40 (Denmark) with TDH39 headphones (Telephonics; Farmingdale, NY, USA). We conducte audiometric testing in a sound-proof booth (background noise\<30dBA) and evaluate the frequency range of 125-8000 Hz. Before the audiometry, patients will be asked to identify which ear have better hearing, and the ear with better hearing was tested first. This study employ the Hughson-Westlake approach, known as the " up-5 down-10 technique." The pure tone sound level was initially introduced at an estimated higher threshold and reduced by 10 dB HL after a correct response from the patient. If the patient did not respond correctly or at all, the sound level was increased by 5 dB HL. When there was a difference of 40 dB HL or more in air conduction thresholds between the ears, contralateral masking was applied to correct the cross-hearing. E200 Audiometry: Noise-canceling headphones (RAN-3500) are used for all patients during the E200 audiometry. This is conducted in a regular room (ambient noise: 42.6-58.7 dBA, measured using a standard sound level meter: AWA6292 Multi-function Sound Level Meter) adjacent to a busy hallway without a sound-proof booth to simulate an ordinary environment. The Hughson-Westlake approach and contralateral masking are applied when conducting the E200 audiometry.