Frequently asked questions

TinniSoothe is a compact wearable white noise device, carefully designed to provide relief for tinnitus. The TinniSoothe module can be worn around the neck on a lanyard, like a necklace, or clipped onto your clothing. With TinniSoothe, you have the flexibility to adjust both the volume and frequency settings to suit your specific tinnitus symptoms. By wearing it throughout the day, the device ensures that a subtle background noise is consistently present. This technique, known as sound therapy or sound enrichment, aims to make your tinnitus less noticeable, especially when transitioning from noisy environments to quiet ones. At night, you place the module into the docking cradle, to initiate night-time settings and battery recharging mode.

Sound therapy involves using soothing sounds to reduce the perception of tinnitus, a condition commonly marked by ringing, whistling or buzzing in the ears. The principle behind sound therapy is that the brain can only concentrate on one stimulus at a time. Therefore, introducing external sounds can provide immediate relief from tinnitus or enhance your ability to concentrate. TinniSoothe delivers a gentle white noise to your immediate vicinity, serving the dual purpose of offering short-term relief from tinnitus and aiding longer-term habituation (getting accustomed to the condition).

Tinnitus is often subjective and so it can be different for everybody. Therefore, we do not claim that TinniSoothe will help everyone. However, if you already find that listening to white noise / ambient sound provides some relief, we are confident that TinniSoothe will help you to find an even better way to manage tinnitus and enhance your lifestyle. TinniSoothe can be effective for both subjective and objective (pulsatile) tinnitus.

View our table of suitability here

TinniSoothe offers practical, discreet, and convenient relief for tinnitus. Its primary function is to provide a distraction from the discomfort caused by tinnitus - usually ringing, whistling or buzzing in one or both ears. One of our trialists described it as follows: "the device is effortless to use and really does the job of ‘taking the edge off,’ which, for a tinnitus sufferer, means a huge amount." In addition to on-the-spot relief when you require it, TinniSoothe can also assist you in the long-term process of habituation, which involves getting accustomed to your tinnitus over time.

TinniSoothe is a British company which was started by a tinnitus sufferer. The founder, Howard Presland, had the sole intent of bringing to market a more practical way to help tinnitus sufferers who find relief from white noise / ambient sound. Howard has suffered from tinnitus for 10 years, ever since a band rehearsal left him with ringing in both ears. He tried everything to find relief - hearing aids, dietary supplements, acupuncture, CBT, hypnosis, even injections through his eardrums - but nothing worked. The only thing that soothed his tinnitus was the use of white noise and ambient sound. Howard then set about inventing a small, wearable white noise device that could provide continuous 24/7 tinnitus relief, without the need to have anything in your ears.

Continuous Support: TinniSoothe is designed to provide a consistent source of gentle sound therapy during the day and at night. During the day, the module can be worn around the neck or clipped to clothing, without anything needing to be placed in or around the ears. At night, it is placed in the docking cradle for night-time settings and recharging. The device should always be kept dry and should not be used where it could be exposed to impact, sweat, moisture or liquid ingress.

Configurability: Over five years of engineering have gone into the product, allowing users to finely tune the white noise output, adjusting both volume and frequency to deliver the perfect level of tinnitus relief. Unlike cheaper alternatives with limited settings for the white noise, TinniSoothe offers a wide range of options. With 60 volume increments and 40 frequency increments, this device offers a remarkable 2,400 permutations to help you find the precise settings that best mask to soothe your tinnitus. Such a level of configurability is unmatched, especially in a device of this size.

Convenience: TinniSoothe is the epitome of convenience. It's the only solution that is both portable and wearable without requiring anything to be placed in or around your ears. Measuring just 59mm (2 1⁄2 inches) and weighing only 16 grams (half an ounce), TinniSoothe is designed to be discreet and easily forgettable, ensuring that neither you nor those around you are bothered by it. With a battery life of at least more than 48 hours, you can take it away for the weekend without worrying about the battery running out or your tinnitus relief being taken away from you. This level of practicality and convenience sets TinniSoothe apart from other, less versatile solutions available on the market.

The combination of these 3 key differentiators makes TinniSoothe truly unique.

TinniSoothe is made in Britain, with manufacturing and assembly taking place across various sites including Oxford, Basildon and Windsor.

At just 59mm (2 1⁄2 inches) and 16 grams (half an ounce), the module has been designed to be both lightweight and discreet, allowing you to just get on with your day without any bother.

Yes, it is certified as a Class 1 medical device in both the UK and the European Union. The MHRA is responsible for regulating the UK medical devices market, and the EMA does the same in the EU. Since it is a non-invasive device which does not enter the body, TinniSoothe is registered as a Class 1 device. This is the lowest-risk class of medical device.

TinniSoothe has been reviewed by Tinnitus UK's expert panel, known as the Professional Advisory Committee. You can read their full treatment sheet on TinniSoothe at https://tinnitus.org.uk/wp-content/uploads/2024/08/TinniSoothe-September-2024-1.pdf

In addition, the Combat Stress Centre for Applied Military Health Research has conducted a feasibility study with TinniSoothe devices. They have also recently published the protocol for a clinical trial at https://www.explorationpub.com/Journals/edht/Article/101165

Here are some ways you can check that we are an authentic British company:

Companies House record:

UK Government Companies House information: https://find-and-update.company-information.service.gov.uk/company/13369186

Regulatory certification as a Class 1 medical device:

UK Medicines and Healthcare products Regulatory Agency (MHRA) Reference number #26491: https://pard.mhra.gov.uk/manufacturer-search/tinnisoothe

Social media accounts:

Instagram: @tinnisootheofficial

FaceBook: tinnisoothe

LinkedIn: @tinnisoothe

TinniSoothe offers an impressive degree of customisation with a total of 2,400 micro permutations available to cater to the unique needs of each user. This level of configurability is achieved through 60 volume increments and 40 frequency settings, all finely adjustable. The device's design ensures that most users can easily find their ideal setting without the need for professional audiologist assistance.

To select the most suitable setting for your tinnitus, clinical experts suggest the following steps:

Start Just Below Your Tinnitus Level

Begin by setting the volume of the device just below the intensity of your tinnitus. The idea is to not completely mask your tinnitus but to provide a subtle distraction and therefore relief. This allows your brain to focus on the device's sound therapy instead of your tinnitus ringing, whistling or buzzing.

Adjust the Frequency

Next, adjust the frequency setting until you find a level that feels soothing or distracting from your tinnitus symptoms.

Trial and Error

You may need to experiment with different frequency settings during the initial days to discover what works best for you and your tinnitus. However, making minor adjustments is straightforward, and you can do it even while on the move.

By following these guidelines to fine-tune your TinniSoothe settings, you can find the optimal configuration that provides relief and helps you manage your tinnitus effectively in the long term.

Usually not, but it depends on volume settings. The subtle sound from the module is directed up towards the user’s ears. Most users typically require only a low to moderate volume, which doesn’t bother people around them. In trials, most users found that other people didn’t hear the device and weren’t conscious of the subtle sound. The vast majority of our trialists reported that friends, work colleagues and family did not notice the sound at all, including at night.

The aim of sound therapy is not to drown out the tinnitus but to provide constant, non-intrusive tinnitus relief by delivering an alternative sound for the brain to focus on. Whilst it may be tempting to occasionally “mask” the tinnitus if it gets really bad, the aim of the device is to distract you from your tinnitus and lessen the attention paid to it. This will be more beneficial over the longer term and enable you to habituate (get used to) to tinnitus. It is also recommended that you gradually lower the volume over a period of several weeks or months, to reduce reliance.

Sound therapy is considered a proven and safe way to achieve relief from your tinnitus symptoms. As such, you can wear the device as little or as much as you want, but keeping it switched on is likely to yield better results, so long as the volume is just below the level of the tinnitus. The less you turn it on and off, the less you will be conscious of your tinnitus when you move from noisy to quiet environments.

It’s important to remember that there is currently no cure for tinnitus. However, many people find that TinniSoothe provides meaningful relief from their symptoms.

Tinnitus is a highly individual and complex condition, so the speed and degree of relief can vary from person to person. In our original trials and through real-world use, many customers reported noticeable relief within the first few days of using TinniSoothe, while for others it may take a little longer to find the most soothing settings.

The journey toward habituation - where your brain learns to pay less attention to the tinnitus - also differs between individuals. Some users only need TinniSoothe for a few weeks or months, while others prefer to use it on an ongoing or as-needed basis.

Outcomes can also be influenced by whether TinniSoothe is used alongside other approaches such as CBT, mindfulness or structured tinnitus support programmes.

We understand that no solution works for everyone. If you do not experience relief, you are welcome to return your device within 30 days for a full refund.

If you have consulted the user guide and still need help, please submit a question using the link at the bottom of this page and we will be happy to help you.

Yes, so long as it is used as intended - see https://tinnisoothe.com/userguide.

TinniSoothe has been categorised as “Safe” by Tinnitus UK in its independent review, which you can read at https://tinnitus.org.uk/tinnitus-treatments/tinnisoothe/

TinniSoothe is also registered as a Class 1 medical device in the UK, and the European Union as a Class 1 medical device. Class 1 devices are a category of device that pose a minimal potential for harm to the user and are generally considered to be low-risk.

TinniSoothe passed all relevant Electromagnetic Compatibility tests in July 2023, pursuant to:

EMC Directive 2014/30/EU and UK Electromagnetic Compatibility Regulations 2016 SI 2016 No 1091; Medical Devices Directive 93/42/EEC and 2007/47/EC and UK Medical Devices Regulations 2002.

As with any electronic device, TinniSoothe should only be used, charged and stored as instructed. The wearable module and docking station are not waterproof or splashproof and should be kept dry.

Do not use the module or docking station where there is a risk of liquid ingress, moisture, sweat, splashing or impact. Liquid ingress can damage the device and may lead to short circuit or overheating. If the device becomes wet, exposed to sweat, damaged, unusually warm, or behaves unexpectedly, stop using it immediately and contact support@tinnisoothe.com.

TinniSoothe is contraindicated for use in the following patient types and scenarios:

Not to be used during pregnancy; Not to be used during breastfeeding, or holding children close under 2 years; Not for use by children aged 12 or under; Not for use with volume set in excess of 80 decibels for a continuous period of eight hours or more; Not to be worn around the neck while asleep;

Please consult your doctor before using TinniSoothe if you are epileptic, have a severe mental illness, have cardiac arrhythmia, wear a cardiac pacemaker or wear a deep brain stimulation device (DBS)

Those with significant motor impairment may find the control buttons problematic; Not to be worn where there is a risk of liquid ingress, sweat, moisture, splashing, impact or short circuit (neither the docking station nor the wearable module are waterproof or splashproof); Not to be left in direct sunlight for a prolonged period, or it may overheat; Not to be used in temperatures below -20 degrees or above 60 degrees Celsius; The wearable module and docking station should be stored and charged above 0 degrees and below 45 degrees Celsius.

Sound therapy is a proven approach to managing tinnitus and there have been many studies as summarised here. TinniSoothe simply re-imagines how sound therapy is delivered, in a more practical, discreet and convenient way. In product testing, over 70% of our trialists experienced a positive outcome from using TinniSoothe.

Tinnitus UK’s independent Professional Advisory Committee has published a Treatment Sheet on TinniSoothe here.

In addition, the Combat Stress Centre for Applied Military Health Research has begun a clinical trial with military veterans, to study the effectiveness of TinniSoothe

Tinnitus UK has a whole section on sound therapy here. They are very clear on best practice: “The aim of sound therapy is to reach a point where the tinnitus is ‘filtered out’ most of the time by the brain, even though it may still be present. This is called habituation. Habituation is probably best achieved if you use sound enrichment at a level that is a little quieter than your tinnitus most of the time. Some people have used masking (playing a loud noise which drowns out the tinnitus) to give themselves a bit of relief. But this approach does nothing to encourage long-term habituation, and it can cause the tinnitus to appear louder when the masking is switched off.”

The BSA regularly updates its Practice Guidance - Tinnitus In Adults. Section 6.2.1 on Sound Enrichment states that “People with tinnitus often describe it as more noticeable or bothersome in a quiet environment, for example at night. Listening to other sounds can make the tinnitus less intrusive (Hobson et al., 2012).

Sound enrichment should be used at a level that is a little quieter than the tinnitus sound. Some people have used masking (loud noise which covers the tinnitus) but this does not encourage habituation and the tinnitus can appear loud when the masking is removed. The choice of sound is a personal one.”

There are no reported adverse side effects. TinniSoothe is a non-invasive product and unlike other miniature white noise devices, it requires nothing to be worn in or around the ears. It is comfortable and relaxing for most users, but we recommend to stop using it if it causes any discomfort. We do not recommend setting the volume above the level of your tinnitus for prolonged periods of ‘masking’. The aim of TinniSoothe is to facilitate long-term habituation.

There is no evidence to suggest that a child would not benefit from using a TinniSoothe device, but we have set an age limit of 14+ to be on the safe side. TinniSoothe does not use WiFi or Bluetooth so it is allowed in exam rooms, in most countries.

If your child has complained of symptoms resembling tinnitus, we recommend you consult with your GP or an audiologist first. You should make you understand what is causing their tinnitus and if sound therapy / sound enrichment is a suitable option.

There are plenty of basic white noise machines on the market to aid sleep for infants. TinniSoothe is a highly configurable device which is specifically aimed at relieving tinnitus.

Please note that we do not recommend pregnant women wear the TinniSoothe module around their neck, nor those carrying a baby on their chest for long periods (eg in a papoose).

Yes.

Yes, but only as intended.

At night, the wearable module should be placed in the docking station beside your bed. This automatically changes the device to your night-time settings and recharges the lithium polymer battery inside the module.

Do not wear the module around your neck while asleep. Do not place the module under your pillow or bedding. Keep the module and docking station dry and away from spilled drinks, moisture, condensation or any risk of liquid ingress.

Yes. There are many studies showing the benefits of an holistic approach to tinnitus management including relaxation, meditation, diet, exercise, and cognitive behavioural therapy (CBT).

We do not recommend wearing the module during sports or other activities where the device could be exposed to impact, sweat, moisture or liquid ingress.

The wearable module is not waterproof or splashproof. Sweat or liquid ingress can damage the device and may lead to short circuit or overheating.

If the device becomes wet, exposed to sweat, damaged, unusually warm, or behaves unexpectedly, stop using it immediately and contact support@tinnisoothe.com.

When used as intended, TinniSoothe emits white noise at a volume of around 82dB, which is within safe noise regulations. The device can reach 90dB when held directly against the ear, but this is not recommended use. When worn around the neck with the lanyard clip, the effective level is closer to 60-65dB, given the extra distance from the ears.

Sound is measured in decibels, which is a logarithmic scale. This means that each step represents a bigger step than the last, they are not equal amounts.

According to RNID, an average spoken conversation is around 60dB, a food blender is around 85dB and an industrial fire alarm is around 97dB.

As a general note, care should be taken if our ears are exposed to long or repeated periods of sound over 85dB. For example in the UK, the Health & Safety Executive legally requires employers to provide hearing protection to employees exposed to 85dB or above, under the Noise Regulations Act 2005.

TinniSoothe has been independently reviewed by the Scientific Advisory Board of Tinnitus UK and has been given a “Safe” rating. In the unlikely event that you experience any discomfort whilst using TinniSoothe, stop using the device immediately and contact us at support@tinnisoothe.com You should also speak to your family doctor or an audiologist to ascertain the root cause of any discomfort.

Yes, however you may benefit from speaking with your audiologist if this is the case.

If you find that TinniSoothe does not help to relieve your tinnitus, you can return the undamaged device and all peripherals in its original package within the first 30 days, for a full refund. We require you to send the package back by tracked mail.

By having a product registered as a Class 1 medical device in the UK and EU, specifically for tinnitus relief, the consumer can be assured of its high quality, safety, and reliability. These registrations indicate that the product has undergone a rigorous assessment and meets the necessary standards set by the UK and EU's regulatory authorities, ensuring it is suitable for its intended medical purpose and poses minimal risk to the user.

The manufacturers of Class 1 medical devices are required to follow certain regulatory requirements, such as good manufacturing practices and quality system regulations. Class 1 devices are categorised as the lowest risk type.

At a typical volume setting of 10 and frequency setting of 15, the battery will last for 48-72 hours.

On average, it takes up to 3-4 hours to charge the battery from zero to full charge. From fully charged, the battery should last at least 48 hours, assuming moderate volume and frequency settings. This means you can take it away for a weekend without the docking station.

No. Only charge the TinniSoothe module in the docking station, using the supplied USB cable.

Do not charge the module directly using a USB-C cable. Charging the module outside the docking station, or using damaged, incorrect or incompatible cables, can damage the module and may invalidate the warranty.

Please also note that the wearable device will only enter night-time mode when it is placed in the docking station.

No, the device has a built-in lithium polymer battery with no ability to swap out. We offer a product warranty of 12 months on any new unit purchased, including the battery.

Yes.

Stop using the device immediately. If the module or docking station is connected to power, switch off the power supply and disconnect it if safe to do so.

Contact us at support@tinnisoothe.com and tell us what happened, including whether the module or docking station was exposed to sweat, moisture, liquid ingress, impact or damage, and what power set-up you were using at the time.

Only charge the TinniSoothe module in the docking station, using the supplied USB cable. Do not use damaged, incorrect or incompatible cables, as this can damage the module and may lead to short circuit or overheating.

We want you to be happy with your purchase and if not, return your device and we will happily refund your money within 30 days.

No. Neither the wearable module nor the docking station is waterproof or splashproof.

Keep both parts dry. Do not use or charge TinniSoothe where it may be exposed to liquid ingress, sweat, rain, splashing, bathrooms, sinks, moisture or condensation.

Liquid ingress can damage the device and may lead to short circuit or overheating. If either the module or docking station becomes wet or exposed to sweat, stop using it immediately and do not charge it.

Liquid ingress may also invalidate the 30-day returns policy and 12-month warranty.

Yes, we offer a product warranty of 12 months on any new unit purchased.