Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older and have had balance problems affecting both ears for more than 1 year, with little or no improvement from standard balance rehabilitation treatment
• Your doctor believes your symptoms are unlikely to improve further with conventional treatment
• You have some degree of hearing loss in the ear to be implanted — ranging from moderate to severe (depending on which stage of the trial you would be enrolled in), but not worse than a certain level (confirm with trial site for exact details)
• You have been diagnosed with a specific balance disorder affecting both inner ears, causing problems such as unsteadiness when walking or standing, blurred vision during movement, or worsening balance in the dark or on uneven ground
• Tests have confirmed that the balance function in both of your inner ears is significantly reduced or absent (confirm with trial site for specific test results required)
• Scans (CT and MRI) show that your inner ear anatomy is suitable for the implant and your balance nerve is intact
• You are able to learn to use the device and follow a personalised rehabilitation programme
• You are well enough to undergo surgery

Who may not be able to join:

• You score above a certain level on standard walking and balance tests, suggesting your balance is not impaired enough (confirm with trial site)
• Your inner ear has bone growth or other structural problems that would prevent the device being fully inserted
• You have a middle ear condition or a type of hearing loss caused by the middle ear (such as conductive hearing loss)
• Your hearing loss originates from the brain or the nerve behind the ear, rather than the inner ear itself
• You have a medical condition that makes surgery unsafe
• You have ongoing severe depression, dementia, or a cognitive (thinking/memory) condition that could interfere with using or assessing the device, in the opinion of the doctor
• You have a type of balance or coordination disorder not related to bilateral inner ear problems (such as certain inherited conditions or cerebellar ataxia without inner ear involvement)
• You have a known genetic condition linked to ataxia (a type of coordination disorder)
• You have been diagnosed with a specific inherited hearing condition called DFNA9
• You have a condition called downbeat nystagmus syndrome (a type of involuntary eye movement disorder)
• You have a condition called Persistent Postural-Perceptual Dizziness (a type of chronic dizziness)
• You are currently taking medications that suppress or reduce balance or dizziness sensations
• You have eye movement disorders, particularly if blurred vision during movement is a main symptom
• You have nerve damage affecting the arms or legs (peripheral neuropathy)
• You have a walking or gait problem caused by certain brain or nervous system conditions such as normal pressure hydrocephalus, multiple sclerosis, or similar disorders
• You have problems with excessive alcohol or drug use
• You have a current psychological or psychiatric condition that could significantly interfere with using or evaluating the device
• You are unwilling or unable to follow the requirements of the trial, as judged by the investigator
• You have unrealistic expectations about what the device can and cannot do
• You work at the trial site or are an immediate family member of someone who does
• You are an employee of Cochlear (the company involved in this trial) or related organisations
• You are currently pregnant or breastfeeding
• You are currently taking part in, or have taken part in another clinical trial involving an experimental drug or device within the past 30 days (unless the trial doctor decides it is acceptable)

Important: Always verify eligibility with the trial site directly before applying.