Frequently Asked Questions:

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1. How does Sono help? What effect does it have on tinnitus?

The effects of Sono vary among different users and include the reduction of tinnitus noise, a decrease in tinnitus occurrences, changes to a softer tinnitus tone, improvements in sleep and mood, and an overall better quality of life.

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2. Is Sono suitable for all types of tinnitus?

Yes, Sono is a suitable treatment for most types of tinnitus, including chronic tinnitus that has not responded to other treatments.

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3. Is Sono contraindicated for any condition?

Sono is contraindicated for certain conditions. Please refer to the list of contraindications provided below in this text. If in doubt, consult your audiologist.

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4. Will Sono work for everyone?

Between 45 and 60 percent of Sono users experience significant improvements in reducing tinnitus perception and associated discomfort.

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5. Have any clinical trials been conducted?

The science behind Sono has been extensively researched in many other peer-reviewed studies.

A noticeable improvement in tinnitus is expected when using Sono regularly in accordance with the instructions for use. The degree of improvement and the timeframe may vary among users.

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6. Your website states that Sono is approved as a medical device for tinnitus. What does that mean?

All medical devices are regulated in the EU and the UK. Cleanhearing Sono has successfully undergone a thorough examination in accordance with EU MDD/MDR requirements for Class IIa medical devices. This is indicated by our CE mark followed by the four numbers (CE 1304).

EU MDD/MDR is a comprehensive and detailed set of regulations that establish a high standard for the quality and safety of medical devices sold in the EU and the UK market, involving ongoing periodic audits by a EU-approved notified body.

 

7. Do I need a prescription from my doctor or audiologist to use SONO?

No, you do not need a medical prescription to use Cleanhearing Sono, but a doctor or audiologist should have reviewed your tinnitus to rule out certain causes. Please also refer to our list of contraindications and discuss any questions with your doctor.

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8. Can I combine SONO with other treatments?

Sono is an independent treatment for tinnitus relief and can also be used in conjunction with other therapies, such as notched music. Ask your doctor or audiologist if Sono is compatible with your existing treatment plan.

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9. Will I experience any side effects?

SONO treatment is comfortable and relaxing for most users. A small number may experience mild and temporary symptoms, such as headaches or muscle pain, which should resolve within 2-10 days as treatment continues.

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10. Is it possible for my tinnitus to get worse when I use Sono?

Temporary aggravation can occur for a small number of users, and it usually resolves within a few days as treatment continues.

If you ever have concerns about changes in your tinnitus, consult your doctor to rule out other causes and contact us for advice and assistance on using Sono.

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11. How will I know if the therapy is working?

Any unusual changes in symptoms can be a sign that the therapy is beginning to work, such as a change in the tone or intensity of tinnitus, or periods when your tinnitus is quieter or absent.

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12.How soon can I expect to feel results?

2-4 months of regular use is typical, and this can vary. Some users will see earlier results, while others may need to use Sono for a longer period. For the best results, use SONO regularly as described in your user manual while relaxing comfortably without distractions.

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13. What if I miss some treatments or can't manage twenty minutes twice a day every day?

Don't worry if you miss a few sessions. Just try to return to a regular schedule as soon as you can. You can still expect results with shorter or less frequent treatments, but progress may be a bit slower.

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14. My tinnitus has improved, but is there a chance it will come back?

Your doctor or audiologist can advise you on how to minimize potential triggers and reduce the chances of your tinnitus returning. Some users continue to use Sono in a reduced "maintenance" program to lessen the likelihood of tinnitus recurrence.

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Side Effects

The SONO device has no serious or permanent side effects. However, some people may experience:

Discomfort or irritation in the area where the applicator is placed.

A sensation of warmth or tingling during or after the session.

Temporary changes in hearing or tinnitus perception.

Fatigue, dizziness, or headache after the session.

These side effects are usually mild and subside shortly. If they persist or are severe, it is recommended to consult with your audiologist.

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Contraindications

The Cleanhearing Sono therapy is not recommended for individuals in the following categories or with the following conditions. Anyone with questions about their medical condition should consult a doctor before using Sono.

Pregnancy; Breastfeeding; Severe hyperthyroidism; Severe hypotension or hypertension; Severe heart arrhythmia; Burn-out syndrome; Blood loss; Severe fungal and bacterial infections; Cancer; Children under 14 years old; Epilepsy; Ear canal infection; Electronic ear implants; Older pacemakers*

(*Cleanhearing Sono application is safe with metal implants or pacemakers compliant with EN50061 or EN 60601-2-31 standards. For patients with older pacemakers or other implanted electronic devices, discuss your medical condition with your doctor before using Cleanhearing Sono).