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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT04145661 Completed - Clinical trials for Cochlear Hearing Loss

Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions.

Start date: November 20, 2019
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT04129775 Completed - Clinical trials for Sensorineural Hearing Loss

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Start date: October 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.

NCT ID: NCT04120181 Completed - Infection Clinical Trials

A New Predictor Marker for Cochlear Implants Infection

Start date: May 2014
Phase:
Study type: Observational

Introduction: Surgical site infections associated with the cochlear implant can have serious consequences. Although advances in surgical techniques reduce these complications, it may be necessary to remove a device that works as a last resort as a result of ongoing infection. The removal of these devices, which are very expensive, increases the cost and takes the chance of hearing patients with this device. Therefore, it is very important to identify patients with a tendency to cochlear implant infection before surgery and to prevent these infections from occurring. Neutrophil/ lymphocyte ratio (NLR) and platelet/ lymphocyte ratio (PLR) are indicative of systemic inflammation and have a prognostic value in relation to mortality and morbidity in many diseases. The aim of this study was to identify patients with post-operative implant infection tendency in patients to be implanted with cochlear implant and to plan treatment for possible infections before cochlear implant, to reduce cost by preventing removal of implanted cochlear implant due to infection and to prevent the patient's chance of hearing through the cochlear implant from disappearing due to infection. Methods: In this retrospective study, 13 patients with cochlear implant infection were included. Preoperative NLR was calculated by dividing the neutrophil (NEU) value by the lymphocyte (LYM) value and preoperative PLR was calculated by dividing the NEU value by the LYM value.

NCT ID: NCT04120116 Completed - Clinical trials for Sensorineural Hearing Loss

FX-322 in Adults With Stable Sensorineural Hearing Loss

Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

This 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.

NCT ID: NCT04048239 Completed - Clinical trials for Cochlear Hearing Loss

Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

ROSA-IC
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

NCT ID: NCT04010721 Completed - Clinical trials for Hearing Loss, Cochlear

Effects of Pulses on Loudness

EfPuL
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.

NCT ID: NCT03993899 Completed - Clinical trials for Sensorineural Hearing Loss, Bilateral

Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Main objective: Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces. Secondary objectives - Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test). - Analyze the link between the results of musical perception tests and the subjective preference of musical listening. - Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements. - Analyze the link between the results of musical perception tests and the results of the perception of speech elements. - Analyze the qualitative multidimensional perception with HDCIS and FS4

NCT ID: NCT03992989 Completed - Hearing Loss Clinical Trials

Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

NCT ID: NCT03951584 Completed - Vestibular Disorder Clinical Trials

Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Start date: May 15, 2019
Phase:
Study type: Observational

Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.

NCT ID: NCT03938753 Completed - Hearing Loss Clinical Trials

Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

Start date: January 9, 2019
Phase: N/A
Study type: Interventional

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).