A Study to Evaluate A Tinnitus Implant System to Treat Chronic Severe Tinnitus

Overview

About this study

The purpose of this study is to evaluate the feasibility of implementing a novel Tinnitus Implant System for suppression of chronic intractable tinnitus.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age: ≥ 18 years of age.
  • Normal to moderate SNHL (≤ 70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥ 75% in the ear to be implanted.
  • Asymmetric subjective tonal tinnitus.
  • Tinnitus present for at least 6 months, but not longer than 5 years.
  • Tinnitus that is disruptive determined by:
    • THI in the severe range (≥ 56/100);
    • TFI in the severe range (≥ 52/100);
    • Tinnitus VAS-A or Tinnitus VAS-L ≥ 50/100.
  • Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking.
  • Normal contrast-enhanced MRI of the head.
  • Normal temporal bone CT.
  • Participants must be able to read, understand, and provide informed consent to participate in the trial.
  • Participants must be willing and anticipate being able to return for study procedures and follow up visits.
  • Participants must have completed participation in the study entitled “Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device” (IRB 17-004832) at Mayo Clinic.

Exclusion Criteria:

  • Age: < 18 years of age.
  • Tinnitus present less than 6 months or longer than 5 years.
  • History of brain or major ear surgery.
  • History of brain or temporal bone tumor(s).
  • Recurrent ear infections within the last year.
  • Prior major head trauma.
  • Presence of clinically significant depressive or anxiety symptoms.
  • GAD-7 score > 9 (indicates clinically significant anxiety).
  • PHQ-8 score > 9 (indicates clinically significant depression).
  • SHAI score > 25 (hypochondriacal level illness anxiety).
  • Currently taking antidepressant, anxiolytic, antipsychotic medication antiepileptic, chronic opioids, or other neuromodulatory agents.
  • Active use of other tinnitus therapies other than use of a non-masking hearing aid.
  • Known pregnancy at time of surgery.
  • Temporomandibular joint dysfunction.
  • Any medical condition, including mental illness or substance abuse, deemed by the PI to likely interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Carlson, M.D.

Contact us for the latest status

Contact information:

Nicole Tombers R.N., CCRP

(507)284-8532

Tombers.Nicole@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20463717

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