The hearing aid market - Italy (2024)

1.2 The global and European market

In ****, the world market for hearing aids is estimated at $*.** billion. Sustained growth of the industry is expected in the near future. A compound annual growth rate (***) of *.**% is projected for the period ****-**** under which the world market could reach a total value of $**.** billion by the end of the period.

Hearing Aid Market World, ****-****, in billions of dollars GrandViewResearch

Regarding the volume of hearing aid sales, there is evidence of sustained growth between **** and ****. During the period analyzed, the total number of devices sold increased from **.** million to **.** million, representing a growth of **.* percent. With the exception of **** (***), growth appears to be steady during the entire period. Hearing aid sales volume World, ****-****, in millions of units Ehima

1.3 The Italian market

As for the Italian market, between **** and ****, the value of production sold of prosthetic objects and appliances (***). Value of production sold of prosthetic objects and appliances (***) Italy, ****-****, in millions of euros Istat As for household spending on the purchase of hearing aids, this again shows growth. Between **** and ****, total spending increased from ***.** million euros to ***.** million euros, representing a growth of **.* percent. However, even in this the outbreak of the pandemic in **** undermined consumption growth. Between **** and ****, the value of spending plummeted by **.* percent, and still in **** the value is lower than the pre-pandemic period (***).

Total household spending on hearing aids Italy, ****-****, in millions of euros Istat

1.4 Import - Export

in order to analyze the import-export of hearing aids, trade flows realtive to products under HS Code ****** "Hearing aids (***) are analyzed.

Between **** and ****, Italy's trade position related to hearing aid trade is that of a net importer. In fact, during the period analyzed, the coverage ratio, determined by the ratio of exports to imports multiplied by ***, remained consistently below *** percent, fluctuating between **.* percent and *.* percent. Specifically, the value of exports decreased by **.* percent, from $**.** million to $*.** million, while the value of imports remained basically stable (***).

Import - export of hearing aids (***) Italy, ****-****, in millions of dollars and & Uncomtrade

In terms of exports, Switzerland is Italy's main trading partner in ****, collecting **.*% of the total value. It is followed by Cuba, the United States and Kazakhstan with **.*%, *.*% and *.*%. The other countries individually do not exceed *% and together contribute **.*% of the total value. Main destination countries for hearing aid exports (***) Italy, ****, % Uncomtrade There is also a strong concentration of value for imports. In ****, the Netherlands contributes **.* percent of the total value of Italian imports. They are followed by Germany and Poland with shares of **.*% and **.*%, respectively. Denmark and France contribute * percent and *.* percent while the other countries together contribute *.* percent of the total. ...

1.5 The consequences of the Russian-Ukrainian conflict

the outbreak of the Russian-Ukrainian conflict in February **** led, among other things, to a general increase in price indexes. However, the sector related to medical devices is not particularly affected by the consequences of the conflict. Analyzing the consumer price index for hearing aids, there is an increase of just *.* points between **** and ****, representing a price increase of *.* percent. Compared to ****, prices increased by only *.*%.

Consumer price index for hearing aids Italy, ****-****, base ****=*** Istat

The consequences of the conflict are most evident on the production side. When analyzing the producer price index for the manufacture of medical and dental instruments and supplies, there is a *.*-point increase between **** and ****, representing a *.* percent increase in producer prices. Compared with ****, production costs have risen by *.* percent. Producer price index for the manufacture of medical and dental instruments and supplies Italy, ****-****, base ****=*** Istat

2.1 Overview of demand

There is a sustained growth in the rate of hearing aid adoption between **** and ****. During the period analyzed, the percentage of those with hearing impairment who use a hearing aid increased from **.* percent to **.* percent. The increase is also evident in relation to the total population: from *.*% in **** to *.*% in ****.

Prevalence of hearing loss and hearing aid adoption Italy, ****, in % Source: ****

The use of hearing aids is then strongly correlated with the severity of hearing loss. The graph below shows that while in less severe cases the adoption rate is **%%, in more severe cases it reaches **% and even **% in cases of maximum loss.

Hearing aid adoption rate, breakdown by severity of loss Italy, ****, % Ehima

2.2 Demand drivers

In order to analyze the drivers of demand for hearing aids in Italy, the age distribution of users, the demographic forecast for the over-** population and the main sources of information used by users are considered.

Regarding the first aspect, there is a marked correlation between age and hearing aid use. In ****, **.* percent of users are over ** years old while **.* percent are between **-** years old. Under the age of **, the share is **.*%.

Hearing aid users, breakdown by age group Italy, ****, % Ehima

Demographic forecasts for the future indicate for Italy a gradual growth of the over-** population and an increase in its percentage weight in the total. Between **** and ****, the total number of people over ** is expected to grow by **.* percent, from **.** million to **.** million. The increase in the number of people over ** will lead to an increase in demand for hearing aids, since, as shown in the graph above, **.* percent of users are over **. Population over ** Italy, ****-****, in millions Istat Finally, in terms of the main sources of information that influenced users' choice, **% recognize the role of their family doctor or audiologist in ****. This is followed by the Internet and specialty stores with shares of **% to **%, respectively. Word of ...

2.3 Geographical distribution of demand

In order to visualize the geographic distribution of demand for hearing aids in Italy, a map was created with the value of average annual household spending on hearing aids.

In ****, the center of the peninsula ranked at the top of the podium for the value of recorded spending. In this area, households spent an average of **.** euros per year on the purchase of hearing aids. This is followed by the North, where spending averaged **.** euros per family. Finally, the South recorded the lowest expenditure value, averaging *.** euros per household (***).

As for the geographical distribution of the population over **, in **** the Northwest of the peninsula tops the national ranking with *.** million people. This is followed by the Center, Northeast and South, with values of *.** million people, *.** million people and *.** million people, respectively. Finally, in the Islands, the over-** population is *.** million people.

3.1 Market organization and dynamics

The structure of the hearing aid market in Italy mirrors the dynamics of the global market. In fact, about **% of the global market share is composed of independent players, generally organized around a few outlets or small chains. About ** percent is represented by retailers, including international players (***), and the remaining ** percent is held by national chains.

Thus, the market is rather concentrated; indeed, the Association for Italian Manufacturers and Importers has about ** percent of the total number of domestic hearing aid manufacturing companies, and consists of ** companies.(***)

The main manufacturers of hearing aids in the Italian market are:

Amplifon s.p.a: was founded in **** in Milan by Algernon Charles Holland, a former British special forces officer involved in the Italian Resistance movement. After the end of World War II, Holland started the company with the goal of assisting those who had suffered hearing loss as a result of the conflict, establishing a widespread local presence and building an organization dedicated to hearing wellness. Amplifon has grown to become a world leader in providing hearing solutions and services, with a network of stores and clinics around the world dedicated to improving the quality of life for people with hearing loss through ...

3.2 The value chain

To develop an effective value chain in the hearing aid market, it is critical to understand the various stages that contribute to the creation and delivery of value to consumers. This industry, characterized by a strong emphasis on technological innovation and customer welfare, requires a detailed analysis of the stages of product development, from initial conception to after-sales support. The value chain in this area is not limited to the mere production of hearing aids, but also embraces research and development of new technologies, customization of products to individual needs, and provision of services that enhance the user experience. Below, an optimized value chain for the hearing aid market is presented:

Research and Development (***): Technological innovation to improve listening quality, reduce size, and increase comfort of hearing aids. Development of advanced software for hearing analysis and customization of hearing aids. Research for more comfortable and less visible materials. Manufacturing: Assembly of electronic components and materials. Strict quality control to ensure product reliability. Flexible manufacturing to adapt to different product needs and customizations. Logistics and distribution: Efficient supply chain management to minimize delivery time. Distribution through multiple channels: hearing aid stores, audiology clinics, online sales. Marketing and sales: Targeted marketing strategies to ...

3.3 Distribution: dominance of hearing aid stores

Business to Business

Production and manufacturing take place in another company, which at a later stage, once the product is complete, sells it to retailers. This methodology is common in the hearing aid value chain, as international manufacturers sell their production to wholesalers or retailers.

Business to Consumer

Production and manufacturing take place in the same company that handles customer interaction and sales.

As mentioned, a large share of the market is in the hands of specialty retailers (***).

Distribution channels for hearing aids Italy, ****, in % Source: ****

4.1 Three types of hearing aids

The components that are common to all models are:

A microphone-Collects sounds and converts them into electrical signals An amplifier - increases the volume of microphone signals and filters out irrelevant sounds A "Loudspeaker" - Converts electrical signals into acoustic signals A receiver - channels the acoustic signals to the eardrum.

As mentioned earlier, hearing aids can be broken down into two macro categories-Custom and Standard. A further distinction can be made based on the location of the device. The picture shows three different types:

BTE (***): behind-the-ear hearing aids are placed behind the ear and channel sound into the ear canal through a thin, transparent tube connected to a custom-made earmold. RIC (***) is covered by a silicone dome, and its position inside the ear canal makes it almost invisible. ITE (***).

The patient's choice of hearing aids depends on several factors obtained through medical diagnosis-performed by an audiogram-and discussion between the physician and the patient. The determining criteria will be:

The intensity of the hearing loss The need for discretion The patient's ability (***) The patient's lifestyle The patient's budget.

4.2 An in-depth look at the BTE and ITE models

About ITEs

ITEs fall into the larger category of CUSTOM hearing aids because of the unique and distinctive features they offer. They are generally connected to a remote control or wirelessly to an electronic device.

IIC (***) are the smallest and most discreet hearing aids available. IIC styles are as described-virtually invisible; indeed, they require removal via a removable lanyard.

Advantages:

Customized Discreet Sound quality Suitable for movement and sports

Disadvantages:

Small problem with dexterity or device connectivity Not suitable for everyone Susceptible to moisture

These styles generally only fit people with mild to moderate levels of hearing loss .

About BTEs

In contrast, BTEs fall into the broader category of STANDARD hearing aids, as they are generally less invasive and more visible to the human eye.

These devices are usually placed on or behind the ear.

Advantages:

Fits all types of hearing loss Less susceptible to moisture Enhanced sound performance

Disadvantages:

Less aesthetically concealed Takes up more space

BTEs are not limited to mild hearing losses, but are suitable for all levels and intensities, including profound hearing losses.

4.3 An average range of prices for different models

taking the consumer price index for hearing aids cited in Section *.* and expanding the period of analysis, it shows that between **** and ****, prices grew by an average of *.* percent. Therefore, unlike other medical and other assistive products, prices for hearing aids have seen a much smaller increase.

Consumer price index for hearing aids Italy, ****-****, base *****=*** Istat

The number of hearing aid variants undoubtedly reflects a diversification of prices. The price differences are not significant among the three different types, as the factors determine the price mainly concern the additional features, capabilities, and components of the hearing aids themselves.

Based on the choice of these additional benefits, hearing aids can be sub-segmented, in fact, into the basic, medium, and high end. These categories can include all three models (***) based on what accessories and technologies these models offer.

(***)

Basic models are also known as *-star devices, rely on digital technology that amplifies the audio signal transmitted to the hearing aid. Mid-range models are also known as *-star devices, often offer wireless connection, and possibly technology to distinguish between speech and background noise. Higher class models are also known as *-star devices, those offer the highest audio performance and are able to ...

4.4 New supply trends: artificial intelligence and machine learning

The integration of artificial intelligence (***)

Machine learning (***)

In ****, the global market for AI-enabled integrated hearing aids reached a total value of $*.** billion. Sustained growth in the industry is expected in the near future. A compound annual growth rate (***) of * percent is estimated for the period ****-**** under which the market could reach a value of $* billion by the end of the period.

AI-powered hearing aid market World, ****-****, in billions of dollars VirtueMarketResearch

5.1 Regulatory framework for the hearing aid market

There are three relevant standards in the hearing aid market: Legislative Decree ***/**, EEC Directive **/**, and Legislative Decree ***/**.

The professional profile of the hearing aid practitioner is regulated by Ministerial Decree (***) ***/**. The article states, "The hearing aid specialist is the health care professional who, holding a qualifying university diploma, carries out his or her activity in the supply, fitting and control of prosthetic devices for the prevention and correction of hearing loss.

European Directive **/** EEC, implemented in Italy by Legislative Decree **/**, concerns the commercial exchange of hearing aids, which are regulated as medical devices.

The directive is based on two essential principles:

Classification of medical devices in relation to their complexity and associated risks Quality and safety requirements

Legislative Decree ***/** "Tariff Nomenclature of Prostheses" classifies devices based on their respective ISO codes into two lists:

- List *: devices that require the intervention of a qualified health care professional;

- Lists * and *: devices that can be acquired directly

As part of List *, hearing aids are intended exclusively for and by the patient for whom they have been prescribed by the medical professional.

5.2 Medical benefits

The ASL " Azienda Sanitaria Loc ale " - Local Health Authority - grants specific categories of patients full reimbursement for the provision of hearing aid. The categories eligible for these benefits are:

All minors, regardless of the degree of diagnosed hearing loss; All patients admitted to accredited health care facilities. In this case, it is not necessary to be in a public hospital, but private clinics are also recognized and affiliated; All disabled persons are certified with at least */* reduction in their ability to work, regardless of the level of certified hearing loss; Disabled persons with a certified hearing loss of at least **db (***) is at least */* of their ability to work; Civilian invalids due to hearing loss or war invalids; All disabled people in the workplace (***)

(***)

6.1 Segmentation

• Amplifon s.p.a
• Cochlear Italia s.r.l
• Maico s.r.l (Demant Italia s.r.l)
• Sonova (Sonova Audiological Care Italia s.r.l)
• Phonak Italia (Sonova Italia s.r.l)
• Bernafon (Demant Italia s.r.l)
• GN Hearing s.r.l
• Advanced Bionics Italia s.r.l