[ Theme VI ] Preset hearing aids vs. custom-made hearing aids : differences and similarities

This article is part of a complete file related to hearing and hearing aids, gathering many questions from Internet users as well as from our customers. You will find the summary of this file on this page as well as the different themes previously discussed below :

• Theme I : What is the interest of a hearing aid ?
• Theme II : Hearing aids and age
• Theme III : Hearing aid and acceptance
• Theme IV : Hearing aid acquisition and reimbursement (France)
• Theme V : How to choose a hearing aid ? What is the best hearing aid ?

The current theme aims to provide complete and detailed information on traditional custom-made hearing aids and preset hearing aids, which have been booming on the market since 2010, in France and around the world.

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A better understanding of the global boom in preset hearing aids

In each sector, a new offer appears when the existing one is insufficient to meet the needs. Thus, to understand the worldwide rise of preset hearing aids since 2010, it seems interesting to first look at how the traditional offer was struggling to meet the needs expressed by people with presbycusis (it is estimated that 20% of the world’s population is equipped with a hearing aid). This initial gap between the traditional offer and the needs seems to stem in part from the very structure of the custom hearing aid market. Historically dominated by three major groups (Amplifon, Sonova and William Demant), this monopolistic market is characterized by a vertical integration of distribution : monopoly and vertical integration have many consequences on the proposed offer.

1 – Custom hearing aids : a monopolistic market

In France and throughout the world, traditional hearing aids (known as “custom-made”) can only be marketed by audioprosthetists, on the basis of a medical prescription from a ENT doctor. Audioprosthetists may be employees of a chain, franchisees or independent. More than 70% of traditional hearing aids are sold by chains.

Below : Market share in units sold, France, 2013 (source : Audika / William Demant – UFC Que Choisir).

This monopolistic situation tends to maintain a consensus on high prices. However, numerous studies have pointed out that one of the main reasons why presbycusic people reject hearing aids is a price that is considered excessive and a significant remaining cost for a hearing problem that is often denied or, when accepted, qualified as a “simple inconvenience”. On the other hand, in some French regions (but also in Italy or Belgium for example), the waiting time for a medical consultation can sometimes be several months, which leads to a real lack of motivation for the people concerned.

2 – Traditional hearing aids : vertical integration of distribution

As UFC Que Choisir pointed out in its 2015 study, hearing aid manufacturers take stakes (total or partial) in the capital of the distribution company and play the role of a “bank” for the latter, by financing its activity. Several consequences emerge from this well-known system, in this sector as in others :

• A lack of neutrality on the part of the audioprosthesist towards his / her client,
• With a preferential orientation of sales towards the manufacturer’s products,
• And a potential brake on innovation (in 2016, the William Demant group’s R&D expenses represented 11% of its total expenses when distribution costs represented more than 80%).

“I wonder about the discomfort that must be felt by the multitude of independent audioprosthesists trapped by this funding and who, today, are prisoners of a competing group.”

P. Boulud, CEO of the manufacturer Silvantos

The Amplifon Group

As a major leader in the global market, in which it holds a 9% stake, the Amplifon Group is present in 22 countries through more than 6,200 direct sales outlets (Amplifon boutique and corners) and 3,300 indirect sales outlets (including 1,400 franchisees and 1,900 affiliates). In 2017, it acquired the Sonova distribution brand – Audionova – and added it to its distribution network, which includes :

• For the Europe, Middle East, Africa zone (EMEA zone) : Amplifon, Beter Horen, Maxtone and Medtechnica Orthophone ;
• For the Americas : Miracle Ear, Elite Hearing Network, Direito de Ouvir ;
• For the Asia Pacific region (APAC region).

The hearing aids products marketed by the Amplifon Group are sourced from the Elite and Miracle Ear buying groups and the brands are Siemens, Beltone (ReSound) and Oticon.

The Sonova Group

In the hearing aid market, Sonova includes the Phonak, Unitron and Hansaton brands. The group has six innovation centers and four operating sites on three continents, more than 50 purchasing centers and 100 independent distributors, as well as a network of 3,300 audiology service sites in 12 key markets. Its revenues are distributed as follows :

• 48% in the EMEA region,
• 42% in the Americas,
• And on the Asia / Pacific zone for 10%.

The William Demant Group

Present in 130 countries with more than 13,000 employees, the Danish group William Demant generates 88% of its turnover from the sale of hearing aids, whose brands are : Philips, Oticon, Bernafon, Sonic, Phonic Ear and Frontrow (it also owns the Sennheiser communications brand). In France, its distribution network includes AudiLab, Auditis and Audika. In 2016, the economic activity of its central purchasing unit increased by 6% and that of its distribution network by 8%. William Demant Group is mainly present in Europe, North America, the Pacific region and Asia.

3 – The French market and its legal evolution

The French market is a dynamic market, which recorded a 5.9% growth between 2000 and 2014. However, when it comes to presbycusis, the rate of people fitted with hearing aids remains relatively low (1 in 4 people) and the needs are significant. Several factors explain this finding :

• The aging of the population, which is accompanied by an increased need for hearing aids ;
• Hearing aids are renewed every 4-5 years ;
• Binaural sales (on both ears) in 80% of cases.

The aging of the population, more rapid than in the past

When we talk about the aging of the French population, INSEE emphasizes that the population will continue to age on January 1st, 2020 and that people aged 65 and over will represent 20.5% of the population on that date. One in 10 inhabitants is over 75 years old. The population projection scenario indicates that if the trend continues by 2040, one in four people will be over 65 years of age and their share could reach 28.7% of the population by 2070, even though the increase in the number of people over 75 years of age would be even more pronounced by that date.

EuroStat makes a similar observation at the European level. For the period 2018-2020, there is a significant aging of the population, where the share of people over 65 years old represents 19.7% (this share is particularly high in Italy, where it is 22.6%). This percentage could double by 2070, with an increase of 9.5 points.

Finally, at the global level, the World Health Organization emphasizes the same trend and predicts that by 2050, the proportion of people over 60 will double, from 12% to 22%. The aging of the world’s population is much more rapid than in the past and all countries must prepare their social systems to face this major challenge.

Major legal developments in recent years (France)

In recent years, France has seen 2 major changes in its legal framework, with the ambition to increase the number of people with hearing aids.

• The Macron law of 2015

The Macron law removes from the Social Security Code, the necessarily inseparable character of the hearing aid, the adaptation and the follow-up over several years (UFC Que Choisir had estimated that this follow-up service, little used by patients, represented 40% of the total amount of the invoice). The objective was to reduce the purchase price of the hearing aid and to allow the user to go to the store of his / her choice for the subsequent follow-up services, according to his / her needs. In reality, however, the Assurance Maladie never recorded this change in its LPPR list (List of Reimbursable Products and Services) and things remained as they were.

• The RAC0 reform of 2018

The Zero-Remaining-Costs reform, led by Agnès Buzyn, made it mandatory to perform the follow-up service and to propose a CLASS I hearing aid offer which are fully covered by Social Security and mutual insurance companies. However, in reality, as 60 millions de consommateurs pointed out in September 2022, the CLASS I offer is only proposed in 10% to 20% of cases, patients being preferentially oriented towards a CLASS II offer (limited coverage, significant remaining-cost and free price) while, at the same time, the mutual insurance package price has increased, mainly for pensioners, the main people concerned by this reform. Today, 70% to 80% of hearing aids sold are CLASS II hearing aids.

4 – The rise of the preset hearing aid offer

The creation and development of preset hearing aids makes sense in light of :

• The global aging of the population (increased need for hearing aids),
• The prevalence of presbycusis in hearing disorders (presbycusis allowing preconfigured hearing aids),
• The massive rejection of traditional hearing solutions for unanimous reasons (high prices, significant remaining expenses, complexity of the care path and / or of the device),
• The risks incurred by these people when they are not equipped with a hearing aid (progressive isolation, depression, cognitive decline, dementia.

It is to respond to this public health issue and to the needs identified in these individuals that the offer of hearing aids has emerged. It provides an immediate, effective and simple solution (without a prescription, OTC) for a fair price.

In France, Sonalto has created the first offer on the market in 2010, by launching the first preset hearing aid product : the Octave BTE, whose maximum amplification is limited to 20dB.

Marketed in a pharmacy in Yvelines, Octave provoked the anger of the audioprosthesists who, through the UNSAF (national association), filed a complaint against the pharmacy for “illegal practice of the profession”. Four years later, in 2014, the court of Versailles ruled in favor of the pharmacy and set a precedent in the matter :

“Pre-tuned listening assistants, with a maximum amplification of 20dB, not requiring the intervention of a health professional, can be sold without a prescription, in pharmacies.”

In 2015, Sonalto was acquired by Urgo and Octave would be deployed in a significant number of national pharmacies. Faced with what appeared to be a threat, a disinformation campaign was set up by the historical players in the sector, aiming to denigrate these preset hearing aids, both in terms of their name and their intrinsic characteristics. Yet, in 2012, an American clinical trial, conducted in a double-blind, placebo-controlled manner, underlined the extent to which these preset hearing solutions, when qualitative, are beneficial for the people concerned and their health.

As of 2016, Sonalto is competing with SERINITI, which offers a complete range of products with the ORISON invisible in-the-ear hearing aid and the AZUR rechargeable mini BTE, and whose website is accessible worldwide.

From then, preset hearing solutions are available internationally at all prices.

Let’s get to the heart of the matter and explain the similarities and differences between custom and preset hearing aids.

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Custom-made and preset hearing aids : the common points

In view of the poor knowledge of the people concerned on the subject, we will try to objectively draw up the main common points between traditional hearing aids (known as “custom-made”) and preset hearing aids.

1 – The name (the nature of the hearing aid)

The name of a preset hearing aid is only controversial for the historical actors who like to distinguish their products, the famous “hearing aids” from the preset products by defining the latter as “listening assistants” or “sound amplifiers”.

A little common sense is needed here, so that everyone clearly understands what it is all about.

Hearing loss occurs when the hair cells in the ear are damaged or destroyed. They do not ensure any more their role of transformation of sound stimulus into nervous message which the brain will interpret. When these cells are damaged or destroyed, they do not regenerate and the hearing loss – as we have already said – is definitive. This hearing loss, especially in the case of presbycusis, is mainly manifested on the high frequencies, while the low frequencies are more or less affected.

What is the role of a hearing aid in this situation ?

Whatever its price, whether it is custom-made or preset, a hearing aid is not intended to make the hair cells of the ear grow back but to amplify the sounds on the damaged auditory frequencies : in other words, whether it is preset or not, a hearing aid is a sound amplifier or even a listening assistant ! To understand this is to accept the idea that these hearing devices are imperfect solutions that will never give you back the hearing you had in your 20s ! It also means understanding that these two types of hearing aids, regardless of their price and settings, are of the same nature and have the same purpose : to compensate for hearing discomfort.

In France, moreover, and in accordance with the European directive on the subject, the law specifies that “the name of the product does not describe its destination (for whom it is intended) or its regulatory status (medical device or not).” Thus, this point of discussion is not one at the legal level, what prevails being :

• The people for whom the hearing aid is intended (hearing impaired VS hearing discomfort) ;
• The regulatory status of the hearing aid (if the product is intended for the hearing impaired, it must be CE marked and is therefore a medical device).

It thus appears that words such as “hearing aid”, “hearing device”, “hearing aid”, “listening assistant” or “sound amplifier” define both a preset hearing aid and a custom-made hearing aid.

2 – On-board electronic components (intrinsic quality of the hearing aid)

In the previous theme, we discussed the on-board electronic components, which determine the quality of the hearing aid. These include the microphone (which picks up sounds), the amplifier (which processes sounds) and the earphone. CE marked hearing aids have the same or similar components, regardless of the final selling price of the hearing aid. Many of these components are manufactured in Asia or Germany. Preset CE marked hearing aids therefore have similar on-board electronics to more expensive hearing aids sold by industry leaders.

3 – Part of the pre-setting

All hearing aids, whether they are preset or custom-made, have a pre-setting made upstream by the manufacturer and guaranteeing the intrinsic functioning of the hearing aid.

Case of custom-made hearing aids

In the case of custom-made hearing aids, a certain number of adjustment channels (3, 6 or more) are left “free” to the audioprosthesists, to allow them to adjust the intrinsic functioning of the device to the audiometric curve of the patient : this is what is called the adjustment of settings, the famous “custom-made”. In the case of an in-the-ear (CIC) hearing aid sale, the “custom fit” also takes into account the user’s ear canal impression.

Preset hearing aids

Preset beforehand (in the case of SERINITI hearing aids, this pre-configuration was carried out by ENT doctors), these hearing aids are ready to use : no further adjustment is possible, other than the volume, by the user.

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Custom-made and pre-configured hearing aids : the differences

There are significant differences between custom-made and preset hearing aids. These differences mainly concern the people for whom these devices are intended as well as the distribution network. Let’s start with some elements.

1 – The people for whom these hearing aids are intended

Custom-made hearing aids and preset hearing aids are not intended for the same people.

Hearing aids on medical prescription

Historically, audioprosthesists have been the only ones in the hearing aid market to offer both hearing impaired individuals (individuals who speak sign language and/or lip reading) and individuals with more traditional hearing loss (presbycusis). Although the needs of these individuals differ greatly, the offer has remained the same :

• Long and regulated care pathway,
• BTE hearing aids,
• Adjustment of settings,
• Follow-up over several years.

• Hearing aids for the disabled

For people with a hearing disability (approximately 700,000 French people), individuals who can neither socialize nor acquire language without a hearing aid, the care pathway is a necessity and is mainly aimed at understanding the problem, as the hearing disability must be detected. This process is not seen as long and complicated, but as a necessity to understand. Many doctors are consulted and then, when the hearing disability is detected and if it can be fitted, the patient is referred to an audioprosthesist who will proceed with the fitting.

The hearing aid is, in this case, an important step in the life of the hearing impaired patient, because it will allow him / her to live a normal life. This step is usually discussed with the ENT specialist, the audioprosthesist and the speech therapist. Indeed :

• The hearing loss is profound and atypical : the hearing aid must necessarily be a BTE with an adjustment of the settings on the audiometric curve of the patient, atypical curve specific to his / her hearing disability ;
• The patient must learn to hear and speak, or even learn Sign Language and / or lip reading ;
• In contact with everyday sounds, adjustments to the settings and follow-up over time are necessary to adjust the technical possibilities of the hearing aid to the patient’s needs as best as possible and allow him / her to have the best possible quality of life.

Today, it is estimated that 90% of people with hearing disabilities are fitted with hearing aids. The cost of these hearing aids is excellent and there is no remaining expense for the patient.

• Hearing aids for presbycusis

Presbycusis is a decrease in hearing acuity that affects everyone with time. Progressive, bilateral and symmetrical, it takes the form of a typical audiometric curve, relatively common, which shows a decrease in hearing on the high frequencies while the low frequencies are more or less well preserved. Presbycusis affects 6 million French people, of whom only 25% are fitted with hearing aids. The unanimous reasons for rejecting hearing aids are :

• The relatively long waiting period for a consultation with an ENT doctor (sometimes up to 6 months);
• The proposal of a visible hearing aid (BTE hearing aids represent 80% of worldwide sales of hearing aids) for people who want a discreet device ;
• The “fear of getting old” ;
• A certain psychological denial ;
• A significant price (3 100€ on average for a bilateral hearing aid, which represents 80% of the sales of hearing aids) and a significant remaining expense ;
• The complexity of the hearing device and its handling.

We can see that if the traditional hearing aid offer is perfectly adapted to the hearing handicap, it is much less so for those who do not always realize by themselves that they hear less well and who do not wish to enter into a long process of hearing aid fitting, with a consequent expense, for a discomfort that they consider to be “a simple annoyance”. Presbycousics are the first to be exposed to the risks of progressive isolation, withdrawal, depression and neurodegenerative diseases linked to not wearing a hearing aid : this is why a range of preset devices has been developed, meeting all their aesthetic and technical needs.

Over-the-counter hearing aids

Presbycusis is, in fact, by its typical curve, a pathology that can be fitted with a preset device. These devices, which can be BTE or ITE / CIC hearing aids, meet the discretion requirements of the individuals concerned. Simple to use, ready-to-hear and available without a medical prescription, they are a powerful, immediate and discreet response to people who want to regain immediate listening comfort at a fair price.

Below : Summary of a typical audiogram of presbycusis hearing loss according to age. A hearing aid finely preset on the damaged auditory frequencies, with the possibility of a variation of volume brings a solution perfectly adapted to this pathology.

2 – The sale of the hearing aid and the distribution network

If custom-made hearing aids are only available with a medical prescription, preset hearing aids are sold over the counter and are available everywhere on the web and in physical sales outlets. Here is an overview.

Hearing aids on medical prescription

These are so-called custom-made hearing aids, the sale of which is necessarily accompanied by an adjustment of the settings on the patient’s audiometric curve as well as an annual follow-up service, for 4 years. These hearing aids are exclusively distributed by audioprosthesists and are only delivered on medical prescription by the ENT doctor who will have performed the audiogram (hearing assessment).

Article L. 4361-1 of the Public Health Code states :

“Is considered as audioprosthesist any person who proceeds to the equipment of the deficient of the hearing. This fitting includes the choice, the adaptation, the delivery, the control of immediate and permanent effectiveness of the hearing aid and the prosthetic education of the hearing impaired person fitted. The delivery of each hearing aid is subject to a prior and mandatory medical prescription for the wearing of a hearing aid, after a tonal and vocal audiometric examination.”

The National Agreement between the health insurance funds and the National Union of French Hearing Aid Practitioners emphasizes that :

“Audioprosthetists shall refrain (…) from draining customers by substituting themselves for doctors through the illegal practice of clinical audiometry, in accordance with the decree of May 2, 1973 (J.O of 18-5-1973) (…) The audioprosthetist can only intervene in execution of a medical prescription and a hearing assessment can only be performed by a doctor. By performing a hearing test, the audioprosthesist replaces the doctor and can be prosecuted for illegal practice of medicine.“

Their sale is conditional on a free 30-day trial.

Hearing aids sold over the counter

Preset, these hearing aids do not need to be adjusted to the user’s audiogram and are therefore sold without a prescription. You can find them just about everywhere :

• On the website of the brands (like Sonalto or SERINITI in France) ;
• On marketplaces (Amazon, La Fnac, Darty, Boulanger, La Redoute, Rakuten) ;
• In pharmacies ;
• In independent or mobile opticians ;
• In some paramedical stores (such as Distri Club Médical in France) ;
• In some supermarkets, such as Boulanger for example.

Note : Hearing aids sold in pharmacies are limited to a maximum amplification of 20dB (case of the Sonalto Octave BTE).

Depending on the place of distribution, their sale is conditioned :

• A “Satisfied or Refunded” offer of 20 to 30 days (on the Internet),
• A legal retraction period of 7 days (in physical sales outlets).

3 – The after-sales service

Whatever the sector of activity, no company today can avoid an after-sales service. Customer satisfaction is essential in the competitive world in which we operate. In the hearing aid market, it takes a different form depending on the nature of the hearing aid : custom-made or preset.

Traditional hearing aids, with a medical prescription

Custom-made hearing aids are, in compliance with the law and the social security code, compulsorily sold with a follow-up service over 4 to 5 years. In 2015, UFC Que Choisir estimated that this service represented 8 hours of work over 5 years for a bilateral hearing aid and accounted for 40% of the total amount of the invoice. UFC Que Choisir further stated that hearing aid users made little or no use of this service – which mainly consists of a possible adjustment of the device’s settings – either because the user did not use their hearing aids or because the store had closed. Regardless of this study, it should be noted that when purchasing a traditional hearing aid, the customer pays in advance for an annual follow-up service for the life of the hearing equipment (4 to 5 years).

Over-the-counter hearing aids

Preset hearing aids are marketed without additional follow-up services, allowing them to be sold at a fair price. Ready to hear, easy to use, they are based on the user’s autonomy. In case of breakage or handling problems, the valuable and serious brands are available by email and telephone to guide the customer, repair the hearing aids and ensure their proper use over time.