114 39 Stockholm, Sweden
Product description Antinitus
Antinitus is a method for relieving discomfort from tinnitus (ringing in the ears), developed and produced in Sweden after many years of research and studies. Antinitus is easy to use, with a painless application. Antinitus is made of materials that are gentle to the skin.
Tinnitus is a common problem that affects approximately 10 to 15% of the population. Tinnitus is a sensation of sound in one or both ears, or inside the head, in the absence of a corresponding external sound source.
Read the instructions carefully before using Antinitus. If you have questions or concerns regarding your condition, you should consult your health care provider.
How exactly does the Antinitus patch work?
Antinitus is a patch designed to reduce discomfort from tinnitus. The patch contains a unique raster – a patented lens that creates an organized signal, which is expected to, directly or indirectly, regulate nerve functions in the auditory system to relieve discomfort from tinnitus. Antinitus is used for relieving discomfort from tinnitus in adults. Antinitus patches are a disposable product that must be replaced daily to achieve the best result.
How is Antinitus used?
Apply the Antinitus patch as described in the APPLICATION instructions. The patch must be replaced daily and worn for 24 hours. Do not use the Antinitus patch for more than 21 consecutive days. Use only one patch at a time.
Apply the patch behind the ear in which you are experiencing tinnitus symptoms. If you have problems with both ears, apply the patch behind the ear with the more serious symptoms. It is a good idea to replace the patch at around the same time everyday, e.g. after breakfast or after taking a shower, to help you remember to apply a new Antinitus patch.
Once the patch has been opened it must be used immediately and replaced daily. The patch must not be reused and the effect cannot be guaranteed. Since tinnitus manifests itself differently in different people, the effect may vary. One experience from the studies is that the alleviating effects increase after the completion of the treatment. You can live normally during the treatment and do not have to make any changes with regard to, for example, exercise, spending time out or indoors or the way you wear your hair.
Does Antinitus work for everybody?
The effect of Antinitus varies between individuals and it does not work for everyone. Antinitus Patches can ease tinnitus symptoms and according to clinical studies 30-50% of Antinitus users experienced relief from their tinnitus symptoms.
Have any clinical studies been carried out on Antinitus?
Three clinical studies of Antinitus® effect on tinnitus has been completed. These showed that many of the patients included in either study experienced relief of symptoms, or the symptoms completely ceased after treatment. Another experience from the studies was that the soothing effect seems to accelerate after the treatment period. Some of those who were in our studies experienced no change at all, and some people experienced improvement of some kind.
Antinitus is safe to use.
What do you mean by relief from tinnitus?
Tinnitus is a subjective experience and is measured through estimates of the person affected. Relief may mean different things for different people, but in the end it is the person affected who decides. For some people, relief is a lower tone or strength of their tinnitus, for others, periods of silence might be the important thing.
When can I expect relief during treatment?
The result is highly individual. Most people who experience relief do so during the 3-week course of Antinitus, others get relief days or weeks after the treatment and some experience no relief at all.
The pitch increases at the start of the treatment, what should I do?
Tinnitus symptoms may increase at the start of treatment, but this normally subsides after a few days.
Can I use Antinitus together with my medication?
Yes, Antinitus has no known effect on pharmaceutical drugs and can be used unless a physician has advised against it.
What is the recommended treatment cycle for Antinitus?
The recommended treatment cycle is 3 weeks. If the tinnitus symptoms increase/return after a round of treatment, the use of Antinitus may be resumed four weeks after the end of the previous treatment cycle.
What does a package of Antinitus contain?
The package contains an inner box of 21 Antinitus patches and instructions for use.
Where do I place the Antinitus patch?
The patch must be placed locally at the cranial base behind the ear associated with the more severe tinnitus symptoms.
If I have tinnitus in both ears, should I wear a patch on each ear?
Apply the Antinitus patch behind the ear in which you are experiencing tinnitus. If you experience problems in both ears, you should apply the patch behind the ear with the more serious symptoms.
Does the Antinitus treatment effect continue after use of the product has been discontinued? If so, for how long?
It is important to complete the treatment for 3 weeks as the clinical studies and the effect of these are based on this treatment duration.
Does the patch work for all kinds of tinnitus?
According to the clinical studies, a wide range of tinnitus patients have been treated and positive effects have been demonstrated.
Can the patches be used to prevent tinnitus?
There are no studies or clinical experience yet in this particular area, so this is not recommended at this point in time.
Can the patches be used to prevent hearing impairment?
No, the patch should not be used in this manner. It is very important to protect one’s ears from harmful sounds and noise in order not to develop, or exacerbate, tinnitus.
I have recently been exposed to loud noises, which has resulted in howling sound in my ears. Should I use Antinitus?
This is a protest from the ears when you have been exposed to a far too high volume of sound. Tinnitus (the howling) usually wears off after at few days, but remember to protect your ears from loud noises in the future. Antinitus is not intended for temporary tinnitus, it should only be used if the tinnitus persists for a long time.
Does the patch work for hyperacusis, so called hypersensitive hearing?
No studies have been carried out in this area, but it will be examined in future studies as experience indicates that there is a positive effect.
Can the patch be used in conjunction with other treatment of tinnitus, such as a noise-blocking device, CBT or TRT?
There are no clinical studies about this, but at the same time there is nothing that contradicts the use of Antinitus in these cases. Consult your physician, therapist or audiologist.
Can the product be worn at the same time as a hearing aid?
Antinitus has no known effect on hearing aids and can be used unless a physician has advised against it.
On which markets is the Antinitus patch approved?
Antinitus is CE marked and approved/registered as a class 1 medical device according to EU Directive 93/42 /EEC and therefore approved for the European market. Antinitus is also approved and registered in Canada, Australia and New Zealand.
Is the Antinitus patch approved in the USA?
We have not yet applied for registration of our ANTINITUS medical device with the FDA and, therefore, the product is not yet approved for the US market. However, we are engaged in the relevant clinical research to support an application for FDA approval and intend to apply for FDA approval in the USA as soon as feasible.
Can I use the product if I am pregnant or nursing?
The use of Antinitus is not recommended during pregnancy or nursing as no clinical studies have been conducted on this group.
Can children use the product?
Antinitus has not been studied in children and must therefore not be used for the relief of discomfort from tinnitus in children below the age of 18 unless prescribed by a physician.
Does Antinitus work on Menière’s disease?
Antinitus may have an effect on tinnitus associated with Menière’s disease, but this has not yet been specifically studied.
Does the patch work for sudden hearing loss/deafness and tinnitus?
In such an event, you should seek medical care immediately. Consult your physician if you have received treatment for this condition and are interested in trying Antinitus.
Must the patch be replaced on a regular basis? If that is the case, why?
Antinitus AB’s risk assessment shows that the main potential risk associated with using the Antinitus patch is getting foreign objects trapped underneath the patch, thus causing irritation. To reduce this risk, it is recommended that the patch is replaced daily and that the skin area is cleaned and dried thoroughly.
How long can the patch stay on and still have an effect?
The patch has been designed and studied for daily replacement and has an effect as long as it is applied on the skin.
Does the patch only work in the local affected area behind the ear?
The effect of the patch has only been studied when placed behind the ear.
Is the product equally effective on all skin types – race/color, age/elasticity?
The product works independently of skin type since the effect takes place on the skin moisture on the surface of the epidermis.
What do I do if the skin becomes irritated underneath the patch?
If the skin becomes irritated you should stop using Antinitus until the irritation has ceased. Treatment can be resumed as soon as the irritation has disappeared.
Can I bathe and/or shower while wearing the patch?
The Antinitus patch is water resistant, but like any other patch it may loosen to some extent in contact with water. Try to replace the patch after showering or bathing every day.
Has any animal testing been carried out in conjunction with Antinitus tests?
No animal testing has been carried out.
How should Antinitus patches be stored?
Store the patches in their box in a dry place at room temperature (18 °C to 25 °C). Keep away from direct sunlight. The expiration date is printed on the package. Once the patch has been opened it must be used immediately and replaced daily. Used Antinitus patches can be discarded with normal household waste or as combustible waste. The box and the instructions for use can be separated as waste paper after the treatment period.