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:

• People aged 18 years or older.
• People with normal hearing or up to moderately severe hearing loss (based on specific hearing test results in both ears).
• People experiencing tinnitus (ringing or noise in the ears) in one ear only, or worse in one ear than the other, where the tinnitus is not a pulsing or beating sound.
• People whose tinnitus has been present for at least 6 months.
• People whose tinnitus is rated as severe on two specific questionnaires (a loudness scale and a tinnitus impact scale).
• People whose tinnitus has not improved enough with standard treatments such as talking therapy (CBT) or hearing aids, where those treatments were considered appropriate.
• People whose tinnitus loudness showed a meaningful reduction during a specific test involving a mild electrical stimulation near the eardrum (confirm with trial site).
• People who are willing and able to sign a consent form agreeing to take part.
• People who are healthy enough to use the device and to have a general anaesthetic for the implant procedure.
• People who are proficient in the Dutch language.

Who may not be able to join:

• People whose tinnitus has a pulsing or beating quality.
• People with structural or anatomical problems in the inner ear, hearing nerve, or brainstem that could affect how the device works, as identified through a CT or MRI scan.
• People with medical reasons that would prevent safe placement or use of the device — including previous brain or major ear surgery, brain or temporal bone tumours, repeated ear infections in the past year, a condition called otosclerosis, or a past serious head injury that resulted in lasting cognitive impairment.
• People with a medical or mental health condition (including substance use issues) that the trial doctors believe could interfere with participation or with understanding the results — including pregnant or breastfeeding women, or people with unrealistic expectations about the trial.
• People with a clinically diagnosed level of depression or anxiety, as measured by specific psychological questionnaires (PHQ-9 or GAD-7 scores above 9).
• People currently taking, or who have taken in the past two months, regularly scheduled antidepressants, anti-anxiety medications, antipsychotics, antiepileptics, or other nerve-affecting medications — unless taken at low doses only as a sleep aid, or used occasionally for specific situations such as travel anxiety (confirm with trial site).
• People currently using other tinnitus treatments (note: hearing aid use may be permitted in certain circumstances — confirm with trial site).
• People who work at the trial site and are directly involved in this study, or their close family members (spouse, parent, child, or sibling).
• People who are employees of Cochlear (the company sponsoring the trial) or of research organisations working with Cochlear on this study.
• People who are currently taking part in, or have taken part in another clinical trial involving an investigational drug or device within the past 60 days (unless it was a Cochlear-sponsored trial and determined not to affect this study).

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