Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

Inclusion Criteria:

• Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)

• Fulfill the American College of Rheumatology clinical and radiological diagnosticcriteria for knee OA

• Are between 50-85 years of age

• Report a frequent pain score between 4-7 (range: 0-10) during the week precedingenrollment

• Report that knee pain negatively affects quality of life

• Are willing not to use any cream, gel, or topical solution during the administrationof treatment other than the approved ultrasound gel provided to the subject at theinitiation of the study

• Are deemed appropriate by their physician or by the study site physician toparticipate.

• Be willing and able to self-administer treatment daily within their place ofresidence or during normal daily activity, excluding bathing, showering, or otherwater activities which may result in submersion of the study device.

• Not use or initiate use of opioid and/or non-opioid analgesic medications.

• Be willing to discontinue any other interventional treatment modalities on the kneeduring the study period (e.g., transcutaneous electrical nerve stimulation,electronic muscle stimulation, traditional ultrasound).

Exclusion Criteria:

• Cannot successfully demonstrate the ability to put on and take off the device.

• Displays any condition which, in the judgment of the investigator, would makeparticipation in the study unacceptable including, but not limited to, the subject'sability to understand and follow instructions.

• Participated in a clinical trial for an investigational drug and/or agent within 30days prior to screening.

• Is pregnant.

• Is a prisoner.

• Is non-ambulatory (unable to walk).

• Has a pacemaker.

• Has a malignancy in the treatment area.

• Has an active infection, open sores, or wounds in the treatment area.

• Has impaired sensation in the treatment area, such as caused by chemotherapy oranesthesia.

• Has a known neuropathy (disease of the brain or spinal nerves).

• Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).

• Have knee replacement, other surgical intervention, or hyaluronidase injection inthe affected knee in the past 6 months.

• Are currently taking steroids.

• Have any contraindication to radiograph.

• Have a secondary cause of arthritis (metabolic or inflammatory).