Tinnitus a problem that affects more than 800 millions of people around the world. Includes the tinnitus current market situation (including the impact of COVID-19), as well as its medium and long term (2030) perspectives.

1. Tinnitus market analysis and
projections
“A problem that affects more than 800
millions of people around the world”
Includes the tinnitus current market
situation (including the impact of
COVID-19), as well as its medium
and long term (2030) perspectives.
January 2021

2. • Persistent tinnitus is a problem that affects 10-15% of
the world's population, which is equivalent to about 800
million people.
• The largest economies in the world are aware of the
problem and are acting. Europe has several projects
underway, ESIT and UNITI being among the most
famous.
• COVID-19 could not only aggravate the effects of
tinnitus but also cause it, being among the long-term
symptoms.
• It is expected that those affected by tinnitus continue to
grow due to the increase in the population, aging,
greater work stress or increased use of headphones to
listen to music or work.
• According to the analysis carried out, it is estimated that
during the first year, an effective drug could reach a
revenue of € 554 million, similar to the amount estimated
by Action on Hearing Loss of $ 689 million.
• Currently, most drugs are in phase one and two, with few
in phase four. On the other hand, most of the companies
come from the United States (36%), followed by
Switzerland and Germany (12%) and the United
Kingdom and Brazil (8%).
• There is a big difference between the investigation of
Tinnitus and other neurological disorders. In 2017,
depression had 30.5 times more scientific publications.
• Governments and private investors are aware of the
need to find a cure for these more than 800 million
people and the opportunity that finding the solution
would bring both in return on investment and in cost
savings for governments.
• A lot of research is being carried out with new
technologies that bring hope for a cure. However, we
must not relax and continue to invest to ensure that
millions of citizens live without suffering.
Key findings

3. Tinnitus - a problem for 800 million people
• Tinnitus is the perception of noise (buzzing, ringing, etc.)
in the ears or head that does not come from any external
source.
• Currently, persistent tinnitus (the one that lasts more
than 6 months and we talk about in this study) affects
about 800 million people around the world.
• As can be seen in the graph to the right, tinnitus reaches
all regions of the world with an affectation rate of
between 10 and 15% (including non-persistent tinnitus it
would increase up to 20% or 40%). Those regions with a
greater population have a greater number of people
affected by tinnitus.
• In this sense, we first find Asia with 57% of the total
affected, followed by Africa (17%), Europe (10%), Latin
America and the Caribbean (8%), North America (7%)
and Oceania (1%).
Source: American Tinnitus Association (ATA), TIN-ACT European Union, Hear-it
AISBL, UN and own analysis.
463; 57%
140; 17%
85; 10%
68; 8%
55; 7% 4; 1%
Distribución de los afectados por tinnitus por
regiones (en millones de personas; porcentaje
sobre el total)
Asia Africa
Europe Latin America and the Caribbean
North America Oceania

4. In the United States, more than 45
million people have tinnitus, being one of
the most widespread health conditions in
the country.
Each year, the US Centers for Disease
Control conducts the National Health and
Nutrition Examination Survey, from which
it can be extrapolated that nearly 20
million people deal with annoying tinnitus
on a regular basis.
Aware of this problem, the US is one of
the countries that invests the most in
tinnitus annually.
In the European Union, an estimated
50.8 million people suffer from tinnitus.
Currently, the European Union is aware
of the problem and have started to work
investing in various projects, being ESIT
and UNITI among the most famous.
On the other hand, they have an app
called Track Your Tinnitus, in which
4,000 patients are monitored for
analysis.
In China, according to a study published
in 2005 by the China Federation of
People with Disabilities, an estimated
130 million Chinese or one in ten
Chinese suffer from tinnitus.
There are many young and middle-aged
people who are affected due to work
stress.
Therefore, specialists in the country are
dedicated to visiting different provinces
to report this hearing problem.
Number of affected in the world's largest economies
Source: ATA, TIN-ACT European Union, Hear-it AISBL.

5. Relationship between COVID-19 and tinnitus
• In 2020, a study was conducted in which 3,103 people affected by
tinnitus from more than 48 different countries participated, mainly from
the United Kingdom and United States.
• It was found that 40% of those showing symptoms of COVID-19
simultaneously experienced a worsening of their tinnitus.
• Of the total affected by tinnitus, around 250 participants reported
symptoms of Covid-19, although only 26 tested positive for the virus.
• Of these 26 positives, 7 participants said they had first noticed changes
in their hearing when they developed COVID-19 symptoms. This would
mean that COVID-19 could not only aggravate the effects of tinnitus but
also cause it, being among the long-term symptoms of COVID.
Source: Anglia Ruskin University with the support of the British Tinnitus Association (BTA) and ATA,
published in the magazine Frontiers in Public Health.

6. Growth forecasts in the population affected by prolonged tinnitus in
the medium and long term
Tinnitus will increase in society due to the
following:
• An increase in population, especially in
countries such as Asia, Africa and Latin
America.
• Aging of the population in regions such as
Europe and the U.S.
• Increased use of headphones to listen to
music or communicate at work with a high
volume.
• Higher stress levels at work.
• Noise pollution in cities: traffic, discos,
concerts, etc.
• Increased use of ototoxic drugs.
• Prolonged symptom of COVID-19.
Source: ATA, TIN-ACT European Union, Hear-it AISBL and own analysis.
0
200
400
600
800
1.000
1.200
2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2050 2100
Estimated number of affected (millions of people)
Asia Africa
Europe Latin America and the Caribbean
North America Oceania

7. Economic cost for the health system and society
• In the United Kingdom, tinnitus treatment has an average cost per person per year of £ 717, reaching a total
amount of £ 750 million per year or 0.6% of the healthcare budget each year (Stockdale, 2017).
• Additionally, society costs are estimated at £ 2.7 billions (Cima, 2012).
• In the United States, tinnitus treatment has an average cost per person per year of $ 660 (Goldstein, 2015),
similar to the UK amount.
• In 2012, $ 1.2 billion were paid to U.S. Veteran’s Administration on tinnitus compensations (ATA) .
• In the Netherlands, a study carried out in 2013 estimated the cost per patient per year at € 1,544 (Maes, 2013).
In this study, the figure is higher since it considered that patients were actively seeking help. Patients from time
to time return to see if there has been any progress that allows their improvement, either with public or private
agents.
Action on Hearing Loss estimates that with the emergence of an effective tinnitus drug the market value the first year of
launch could be worth $ 689 million.

8. 0
200
400
600
800
1.000
1.200
1.400
1 2 3 4 5 6 7 8 9 10
Annual revenue in millions of euros
North America Europe
Asia Latin America and the Caribbean
Africa Oceania
Estimation of the potential market for an effective drug
• According to the analysis perform, it is
estimated that the first year, this drug could
reach a revenue of € 554 million, similar to
the amount estimated by Action on Hearing
Loss of $ 689 million.
• During the first year the drug would be sold in
the US, Europe and Oceania, while during
the second and third year it would begin to be
marketed in the rest of the regions. The
amounts would reach € 779 million and €
1,034 million, respectively.
• It has only been considered that approx. 1%
of those affected are seeking active help
every year.
• The price of the drug has been adjusted
according to the GDP per capita of each
country. Establishing as a base a price for
Europe of about € 300 per patient.
Source: UN and own analysis.

9. Number Company Country Drug Compound Phase
1 Antwerp University Hospital Belgium Deanxit Flupentixol/Melitracen Phase 4
2 HaEmek Medical Center Israel Lidocaine n.a. Phase 4 (recuiting)
3 Otonomy, Inc. United States OTO-313 Gacyclidine Phase 2
4 GlaxoSmithKline United Kingdom Vestipitant n.a. Phase 2
5 Tinnitus Research Initiative n.d. Zinc n.a. Phase 2
6 Tinnitus Research Consortium United States n.a. Gabapentin Phase 2
7 Sensorion SA France SENS-401 Arazasetron besylate Phase 2
8 Norvartis AG Switzerland BGG492 Selurampanel Phase 2
9 Hough Ear Institute/Oblato, Inc. United States NAC/HPN-07 / NHPN-1010 n.p. Phase 2
10 NeuroSystec Corporation United States NST001 Gacyclidine Phase 1 (finished)
11 Oregon Health and Science University United States Acamprosate N-acetyl homotaurine Phase 1
12 Bayer AG Germany BAY38-9456 Vardenafil Hydrochloride Trihydrate Phase 1
13 St Joseph University Lebanon Sulodexide n.a. Phase 1
14 AudioCure Pharma GmbH Germany AC102 n.p. Phase 1
15 Frequency Therapeutics United States FX-322 n.p. Phase 1
16 Knopp Biosciences LLC United States Kv7 modulator n.p. Preclinical
17 Auris Medical Holding AG Switzerland AM-102 n.p. Preclinical
18 Cognosetta Inc. United States CS0022 n.p. Preclinical
19 Gateway Biotechnology Inc./NEOMED United States GW-201 Tetrandrine Preclinical
20 Korea Otsuka Pharmaceutical Co., Ltd. Korea Pletaal Cilostazol n.p.
21 Otosul -Otorrinolaringologia Sul Fluminense Brazil Piribedil n.a. n.p.
22 Otosul -Otorrinolaringologia Sul Fluminense Brazil Syntocinon Oxytocin n.p.
23 Auris Medical Holding AG Switzerland Keyzilen (AM-101) S-ketamine hydrochloride Phase 3 (failed)
24 Merz Pharmaceuticals GmbH Germany Neramexane Neramexane mesylate Phase 3 (failed)
25 Autifony Therapeutics Ltd. United Kingdom AUT00063 n.a. Phase 2 (failed)
Current investigations by phase, company, country and drug
Most drugs are in phase one and two, with few in phase four. On the other hand, most of the companies come from the
United States (36%), followed by Switzerland and Germany (12% each) and the United Kingdom and Brazil (8% each).
Source: An update: emerging drugs for tinnitus, Christopher R. Cederrotha, Jonas Dyhrfjeld-Johnsenb y Berthold Langguthc. Tinnitustreatmentreport and own analysis.

10. Research in Tinnitus is lower than other neurological disorders
• In the study conducted by J. McFerran, Why there is no cure for Tinnitus ?, in 2019, the research done on Tinnitus was
compared with other neurological disorders.
There is a big difference between the investigation of Tinnitus and other neurological disorders. In 2017, depression had 30.5
times more scientific publications. If we focus on drug therapies, the data get worse, with 49 times more publications in relation
to depression during the same year.
Source: J. McFerran, Why there is no a cure for Tinnitus?, 2019
List of trials registered in clinicaltrials.gov List of publications registered in PubMed
Condition
Total
registered
trials
Interventional
trials using
drungs
Chronic pain 2.235 855
Depression 5.590 2.440
Anxiety 2.826 921
Hearing loss/deafness 494 94
Tinnitus 200 55

11. • In 2020, Neuromod (an Irish and German collaboration) published a trial conducted with 326 patients for 12
weeks, indicating that 86.2% of patients who had completed the treatment saw an improvement of about 14
points in a score tinnitus from 1 to 100. When the team followed up 12 months after treatment, 80.1% of the
participants had maintained improvements. The study represents the largest and longest follow-up clinical trial
ever conducted in the field of tinnitus. 78% of the trial participants said they would recommend the Lenire
treatment.
• Subsequently, Neuromod raised € 10.5 million in a financing round - Series B. The investment was led by
majority investor Fountain Healthcare Partners, with the participation of existing investors Moffett Investment
Holdings and Medical Device Resources, with venture-debt provided by Kreos Capital and Silicon Valley Bank.
Latest trends in the fight against tinnitus
• The European Union through its Horizon 2020 research and development program has invested € 3.8 million in
2017 (ESIT) and € 6 million in 2020 (UNITI). The latter with the aim of developing a predictive computational
model based on longitudinal data to address which treatments are optimal for each of the cases.
Governments and private investors are aware of the need to find a cure for these more than 800 million people and the
opportunity that finding the solution would bring both in return on investment and in cost savings for governments.

12. Latest trends in the fight against tinnitus
• Mehrnaz at the Bionic Institute in Melbourne, Australia has developed an artificial intelligence that can detect
tinnitus. This technology, functional near-infrared spectroscopy (fNIRS), has an accuracy in detecting tinnitus of
78% and distinguishes between mild and severe forms with 87% accuracy.
• Use of Biobanks to carry out new research. The BTA has joined with NIHR Nottingham Biomedical Research
Center and the University of Nottingham and Newcastle to investigate using image data from thousands of
brain scans performed at the UK Biobank.
• The UK Biobank has found a possible association between tinnitus and RCOR1 gene variation.
A lot of research is being carried out with new technologies that bring hope for a cure. However, we must not relax and
continue to invest to ensure that millions of citizens live without suffering.
• Both the British Tinnitus Association (BTA) and the American Tinnitus Association (ATA) remain very active in
the fight against Tinnitus. The BTA has donated £ 125,000 to King's College London and the University of
Nottingham for a research that could predict who will develop tinnitus, as well as £ 118,000 to the team at
Macquarie University in Australia for a study that aims to develop an objective way to measure tinnitus. In the
other hand, ATA received a donation of $ 2.7 million in 2020, which will be used to finance long-term strategic
research on tinnitus.

13. For a definitive
cure, for a
better world.
Thank you all!