Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 73 trials
NCT06960616
The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.
NCT06492993
Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.
NCT06734039
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.
NCT04793412
This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.
NCT07416292
ListenFuture, a nation-wide multidisciplinary project, brings new knowledge on complex associations between listening, cognition, language, literacy, and psychosocial wellbeing in deaf and hard-of-hearing (DHH) adolescents. Earlier findings indicate that DHH adolescents remain at a risk to achieving age-appropriate skills. The associations among these skills can also be language-dependent. The investigators use behavioral methods and questionnaires. The investigators study speech perception in noise, listening, and listening-related fatigue to reveal how DHH adolescents cope in today's noisy environment. The investigators study cognitive skills and executive functions, spoken language and literacy skills to find out the current state-of-knowledge. The investigators study psychosocial wellbeing, school burnout and factors associated with them. The investigators will utilize supervised and interpretable machine learning to analyse the performance domains that could best predict the outcomes of DHH adolescents. The investigators expect our project to have broad societal impact for DHH adolescents, healthcare, school, and other stakeholders.
NCT04888143
360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment. Cochlear implants are indicated in severe to profound deafness in some cases. The principle of the cochlear implant is to directly stimulate the fibres of the auditory nerve via electrodes inserted into the cochlea. It stimulates the auditory nerve and sends electrical impulses to the brain where they are interpreted as sounds. The steps in hearing rehabilitation are surgical placement of the cochlear implant, activation, and follow-up adjustments. There is no formal consensus on the exact adjustment procedures during activation or follow-up, but principles are followed depending on the cochlear implant adjustment centers (jack). All centers focus on sound intensity adjustments to achieve the goals of tonal audiometry in open-field silence with cochlear implant alone between 20 and 40 db (30 db most frequently). However, it is common practice to observe that this means of assessment does not really represent the performance of the individual because hearing a sound does not mean that someone will be able to recognize it and interpret it. Some of the patients who achieve these goals have difficulty hearing well in a noisy environment. Speech audiometry in silence and especially in noise would be a better reflection of patient needs. Bimodal hearing is having a cochlear implant and a contralateral hearing aid. In cochlear implants, having bimodal binaural hearing improves the patients ability to understand speech in silent and noisy contexts. It should thus be considered when a second cochlear implant is not indicated in the contralateral ear. It has been shown that intelligibility and musical perception are altered when the frequency allocations are different from the manufacturer's default frequency allocations. The possible redundancy between the acoustic and electrical information on the contralateral ear can lead to metallic distortion of the voice, which is perceived as less natural. This is due to a different stimulation of the cochlear tonotopic zones concerning conversational frequencies, between the implanted side and the device side. However, the frequency distribution is not subject to adjustment in current practice. A modification of the frequency distribution is possible on cochlear implants, which could improve the intelligibility and comfort of the implanted patient. This working hypothesis will be studied, and a simple protocol for frequency reallocation of the cochlear implant will be developed to optimize the daily hearing performance of the implanted patients. An evolutionary algorithm will be used. The search for new adjustment solutions will be carried out within the safety limits imposed by the adjusters (detection and comfort loudness threshold).
NCT07156461
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness. The main questions this study aims to answer are: * Do the findings confirm the clinical performance of the Osia 3 Sound Processor? * Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor? Participants will: * Undergo speech performance testing in both quiet and noisy environments * Provide ratings for a self-reported questionnaire
NCT07081542
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use. The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care. This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.
NCT00400413
The aim of the research is to investigate phonological processing in deafness and to examine its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the ability to read is closely related to the ability to segment and represent speech units, the neuroanatomy of reading in deaf would be different from the one of hearing readers.
NCT02102256
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.
NCT07161154
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.
NCT04183348
We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized. Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.
NCT02323256
This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.
NCT05379231
22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.
NCT05775367
The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.
NCT02189798
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
NCT06929468
The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.
NCT05402813
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
NCT05000931
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.
NCT05942261
The goal of this observational study is to describe the type of the rehabilitation method for italian children with cochlear implant . The main questions are: What is the most used rehabilitation methods in implanted children? Which is the prevalence of each method related to the clinical features of the patients?