Wear-Time Trial for Self-Fitting Hearing Aid
Hearing LossSensorineuralThis document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (GN) self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.
FX-322 in Adults With Stable Sensorineural Hearing Loss
Sensorineural Hearing LossNoise Induced Hearing Loss1 moreThis is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects...
Sensorineural Hearing LossThis is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
Short-term Oral Steriods for Acute Tinnitus
TinnitusSubjective2 moreThe goal of this clinical trial is to learn about the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of prednisone and/or oral Ginkgo Biloba tablets.
Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead...
Sensorineural Hearing LossBilateral1 moreThe investigators are interested in an additional hearing aid feature called non-linear frequency compression (NLFC). This aims to improve audibility of high frequency sounds by converting them into lower frequencies and has been shown to benefit those with moderate-severe sensorineural hearing loss (SNHL). Cochlear dead regions (DRs) are areas of the inner hearing organ (the cochlea) where there is little or no function and are commonly found in regions responsible for detecting high pitched (frequency) sounds. Not all people with hearing loss have DRs. The investigators would like to determine whether based on the presence or absence of DRs, patients with moderate-severe SNHL perform better or prefer their hearing aids programmed conventionally, or with NLFC activated. To do this, two participant groups will be created based on findings from the threshold equalising noise (TEN) test which identifies cochlear DRs. Two participant groups will be created; one group with DRs and one group without DRs. All participants will receive two hearing aids and will wear these programmed conventionally for ~six weeks and with NLFC activated for ~six weeks in a counterbalanced manner. Following each condition, participants will complete a questionnaire and various speech tests will be performed. This involves participants repeating sentences, words or speech sounds they hear from a speaker in quiet and in the presence of background noise. Individuals' scores will be calculated for each test and their performance when NLFC was activated and deactivated will be compared. This will be analysed alongside the questionnaire data to compare the 'DR' and 'no DR' group in both conditions. Findings may help to determine whether NLFC should be activated for all moderate-severe SNHL patients, or just those with DRs, helping clinicians to optimise hearing aid settings for patients.
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically...
Sensorineural Hearing LossTo assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor...
Deafness; Sensoneural Single SidedConductive Hearing Loss1 moreThe aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).
Training Language and Literacy for Children Who Use CIs
Hearing LossSensorineuralThis study aims to determine the effectiveness of computer games to improve language and literacy outcomes for children who have hearing loss. Children will be assigned to one of four conditions: phonological awareness training, working memory training, phonological awareness + working memory training, or active control.
Expanded Indications in the Adult Cochlear Implant Population
Hearing LossSensorineuralThe purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.
Cognition Effects of Hearing Aids and Auditory Training in Older Age
Hearing LossSensorineuralSensorineural type of hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. There is no clinically proven method to predict the onset of this condition, as its occurrence is slow and progressive, affecting both ears equally. Although hearing aid use and auditory training have been proven as successful interventions to alleviate sensorineural hearing loss, no research has been designed to look at the effect of both hearing aid use coupled with auditory training on cognitive performance in older adults. This study will investigate whether wearing hearing aids will improve the impact of auditory training on cognition, mood and social interaction for older adults with sensorineural hearing loss. This is a crossover trial targeting older adults between 50 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will undergo a six month intensive auditory training program (active control), as a rigorous means of examining the impact hearing aid use has on a person's cognition, mood and social interaction. Participants will be assigned in random order to receive hearing aid (intervention) for either the first three or last three months of the six month auditory training program. Each participant will be tested at baseline, three and six months on a battery of computer based cognitive assessments, together with mood, and social engagement measures. Effectiveness of hearing aids and auditory training will be evaluated using an online speech perception test (SPT) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) Inventory. This study will investigate whether using a hearing aid coupled with auditory training can improve a person's cognition and learning abilities, relationships with family and friends, and quality of life. Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials.