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 of age or older at the time you give your consent to join.
• The ear to be implanted has significant hearing loss, measured at a level of 70 dB or worse across key sound frequencies (this is a specific hearing test result — confirm with trial site).
• Even with a hearing aid, you can correctly identify 40% or fewer words on a word recognition test in the ear to be implanted.
• Your other ear also has some degree of hearing loss, measured at 30 dB or worse across key sound frequencies (confirm with trial site).
• You are a fluent speaker of the language used to test your ability to understand speech, as decided by the research team.
• You have regular access to a compatible smartphone.
• You are willing and able to sign a written consent form to participate.

Who may not be able to join:

• You have already had a cochlear implant in either ear, or you are planning to get one in the opposite ear during this study.
• You have hearing loss in only one ear, as determined by the research team.
• Your hearing loss is caused by a growth or problem inside the brain or on the hearing nerve connected to the ear to be implanted.
• You have had an ear infection in the ear to be implanted at the time of surgery or within the 3 months before joining the study.
• You have a hole in your eardrum, or you have had ear surgery in the past 3 months, in the ear to be implanted.
• You have been diagnosed with a condition called auditory neuropathy in the ear to be implanted (confirm with trial site).
• There is a blockage, unusual shape, or other structural problem inside the ear to be implanted that might prevent the device from being fully inserted.
• You currently have a drain or shunt in your spinal fluid system, a fluid leak around the inner ear, a skull fracture, or a spinal fluid leak.
• You had severe or profound hearing loss in both ears before the age of 5, based on what you report.
• You have had severe or profound hearing loss in the ear to be implanted for more than 20 years, based on what you report.
• You have a medical or psychological condition that makes surgery or general anaesthesia unsafe for you, as decided by the research team.
• You have a skin condition that could affect wound healing, such as psoriasis, dermatitis, uncontrolled diabetes, or long-term use of steroid creams, as judged by the research team.
• The research team feels you have unrealistic expectations about what the device or surgery can achieve.
• You have additional physical or other difficulties that could affect your safety or ability to take part in the study.
• You are unwilling or unable to follow all the requirements of the study, as decided by the research team.
• You are currently pregnant or breastfeeding.
• You or a close family member (spouse, parent, child, or sibling) work directly at the site running this trial.
• You are an employee of Cochlear (the company sponsoring the trial) or of any organisation contracted by Cochlear for this study.
• You are currently taking part in, or have taken part in, another clinical study involving an experimental drug or device within the past 30 days (unless it is another Cochlear-sponsored study and the research team determines it is not a problem).

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