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A middle ear implant is a hearing device that is surgically implanted into the
middle ear The middle ear is the portion of the ear medial to the eardrum, and distal to the oval window of the cochlea (of the inner ear). The mammalian middle ear contains three ossicles, which transfer the vibrations of the eardrum into waves in the ...
. They help people with conductive, sensorineural or mixed
hearing loss Hearing loss is a partial or total inability to hear. Hearing loss may be present at birth or acquired at any time afterwards. Hearing loss may occur in one or both ears. In children, hearing problems can affect the ability to acquire spoken l ...
to hear.   Middle ear implants work by improving the conduction of
sound In physics, sound is a vibration that propagates as an acoustic wave, through a transmission medium such as a gas, liquid or solid. In human physiology and psychology, sound is the ''reception'' of such waves and their ''perception'' by ...
vibrations from the middle ear to the
inner ear The inner ear (internal ear, auris interna) is the innermost part of the vertebrate ear. In vertebrates, the inner ear is mainly responsible for sound detection and balance. In mammals, it consists of the bony labyrinth, a hollow cavity in th ...
. There are two types of middle ear devices: active and passive. Active middle ear implants (AMEI) consist of an external audio processor and an internal implant, which actively vibrates the structures of the middle ear. Passive middle ear implants (PMEIs) are sometimes known as ossicular replacement prostheses, TORPs or PORPs. They replace damaged or missing parts of the middle ear, creating a bridge between the outer ear and the inner ear, so that sound vibrations can be conducted through the middle ear and on to the cochlea. Unlike AMEIs, PMEIs contain no electronics and are not powered by an external source. PMEIs are the usual first-line surgical treatment for conductive hearing loss, due to their lack of external components and cost-effectiveness. However, each patient is assessed individually as to whether an AMEI or PMEI would bring more benefit. This is especially true if the patient has already had several surgeries with PMEIs.


Active middle ear implant


Parts

An active middle ear implant (AMEI) has two parts: an internal implant and an external audio processor. The
microphone A microphone, colloquially called a mic or mike (), is a transducer that converts sound into an electrical signal. Microphones are used in many applications such as telephones, hearing aids, public address systems for concert halls and publ ...
of the audio processor picks up sounds from the environment. The processor then converts these acoustic signals into
digital signal A digital signal is a signal that represents data as a sequence of discrete values; at any given time it can only take on, at most, one of a finite number of values. This contrasts with an analog signal, which represents continuous values; a ...
s and sends them to the implant through the skin. The implant sends the signals to the Floating Mass Transducer (FMT): a small vibratory part that is surgically fixed either on one of the three
ossicles The ossicles (also called auditory ossicles) are three bones in either middle ear that are among the smallest bones in the human body. They serve to transmit sounds from the air to the fluid-filled labyrinth (cochlea). The absence of the auditor ...
or against the round window of the
cochlea The cochlea is the part of the inner ear involved in hearing. It is a spiral-shaped cavity in the bony labyrinth, in humans making 2.75 turns around its axis, the modiolus. A core component of the cochlea is the Organ of Corti, the sensory o ...
. The FMT vibrates and sends sound vibrations to the cochlea. The cochlea converts these vibrations into nerve signals and sends them to the brain, where they are interpreted as sound.


Indications

AMEIs are intended for patients with mild-to-severe sensorineural hearing loss, as well as those with conductive or mixed hearing loss. They can be used by adults and children over the age of 5.


Sensorineural hearing loss

An AMEI can be beneficial for patients with mild-to-severe sensorineural hearing loss who have an intact ossicular chain and healthy middle ear, but who either cannot wear
hearing aid A hearing aid is a device designed to improve hearing by making sound audible to a person with hearing loss. Hearing aids are classified as medical devices in most countries, and regulated by the respective regulations. Small audio amplifiers s ...
s or who do not get sufficient benefit from them. Reasons for not being able to wear hearing aids include earmold
allergies Allergies, also known as allergic diseases, refer a number of conditions caused by the hypersensitivity of the immune system to typically harmless substances in the environment. These diseases include hay fever, food allergies, atopic dermat ...
, skin problems, narrow, collapsed or closed
ear canal The ear canal (external acoustic meatus, external auditory meatus, EAM) is a pathway running from the outer ear to the middle ear. The adult human ear canal extends from the pinna (anatomy), pinna to the eardrum and is about in length and in di ...
s, or malformed ears. In cases of sensorineural hearing loss, the FMT is usually attached to the incus.


Conductive or mixed hearing loss

An AMEI is also indicated for patients with conductive or mixed hearing loss with
bone conduction Bone conduction is the conduction of sound to the inner ear primarily through the bones of the skull, allowing the hearer to perceive audio content without blocking the ear canal. Bone conduction transmission occurs constantly as sound waves vibra ...
thresholds from 45 dB in the low
frequencies Frequency is the number of occurrences of a repeating event per unit of time. It is also occasionally referred to as ''temporal frequency'' for clarity, and is distinct from ''angular frequency''. Frequency is measured in hertz (Hz) which is e ...
to 65 dB in the high frequencies. In these cases, the FMT can be coupled to various parts of the middle ear, depending on the patient’s
pathology Pathology is the study of the causes and effects of disease or injury. The word ''pathology'' also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when used in ...
: * The
oval window The oval window (or ''fenestra vestibuli'' or ''fenestra ovalis'') is a membrane-covered opening from the middle ear to the cochlea of the inner ear. Vibrations that contact the tympanic membrane travel through the three ossicles and into the in ...
, causing stimulation of the cochlea in patients without an ossicular chain. * The
round window The round window is one of the two openings from the middle ear into the inner ear. It is sealed by the secondary tympanic membrane (round window membrane), which vibrates with opposite phase to vibrations entering the inner ear through the oval ...
, causing reverse stimulation of the cochlea in patients without an ossicular chain. * The mobile
stapes The ''stapes'' or stirrup is a bone in the middle ear of humans and other animals which is involved in the conduction of sound vibrations to the inner ear. This bone is connected to the oval window by its annular ligament, which allows the foo ...
in patients with absence or fixation of other ossicles, usually in cases of chronic
otitis media Otitis media is a group of inflammatory diseases of the middle ear. One of the two main types is acute otitis media (AOM), an infection of rapid onset that usually presents with ear pain. In young children this may result in pulling at the ear, ...
or
malformations A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can r ...
.


Efficacy

AMEIs have been shown by several studies to be equal or superior to both hearing aids and bone conduction implants. Lee et al used the PBmax test to study speech intelligibility in patients before and after receiving an AMEI. All patients had used hearing aids pre-implantation. The researchers found that speech intelligibility improved with the AMEI, particularly in patients with a down-sloping hearing loss. These findings were supported by Iwasaki et al, who found that both speech intelligibility and
quality of life Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards ...
improved after implantation with an AMEI, applied to the round window. AMEIs can also offer improved hearing performance over bone conduction implants for patients with mixed hearing loss. Mojallal et al found that patients whose mixed hearing loss was treated with an AMEI experienced both better
word recognition Word recognition, according to Literacy Information and Communication System (LINCS) is "the ability of a reader to recognize written words correctly and virtually effortlessly". It is sometimes referred to as "isolated word recognition" because i ...
and speech understanding in noise than those who received a bone conduction implant, providing that their bone conduction pure-tone average (0.5 to 4 kHz) was poorer than 35 dB HL.


Passive middle ear implant


Parts

Passive middle ear implants (PMEI) are ossicular replacement prostheses designed to replace some or all of the ossicular chain in the middle ear.  They create a bridge between the outer ear and the inner ear, so that sound vibrations can be conducted through the middle ear and on to the cochlea There are two types of PMEIs:
tympanoplasty Tympanoplasty is the surgical operation performed to reconstruct hearing mechanism of middle ear Classification Tympanoplasty is classified into five different types, originally described by Horst Ludwig Wullstein (1906–1987) in 1956. # Type ...
implants and stapes implants.  Tympanoplasty implants (also known as PORPs or TORPs) are suitable for patients with a mobile stapes footplate, ie. a stapes footplate that moves in the normal way. Either a partial or a total tympanoplasty implant can be used, depending on the condition of the stapes. If the stapes is fixed and cannot transfer vibrations to the inner ear, then a stapes implant would be used.{{Cite web, title=Passive Middle Ear Implants {{! MED-EL Pro, url=https://www.medel.pro/products/passive-middle-ear-implants, access-date=2021-12-13, website=www.medel.pro, language=en PMEIs are made from different materials including titanium, teflon, hydroxylapatite, platinum, and nitinol, all of which are suitable for use within the human body.  Titanium implants can safely undergo MRIs of up to 7.0 Tesla.


Indications


Tympanoplasty implant

The tympanoplasty implant is indicated in cases of congenital or acquired defects of the ossicular chain, due to e.g.: * Chronic otitis media * Traumatic injury * Malformation *
Cholesteatoma Cholesteatoma is a destructive and expanding growth consisting of keratinizing squamous epithelium in the middle ear and/or mastoid process. Cholesteatomas are not cancerous as the name may suggest, but can cause significant problems because of th ...
It can also be used to treat patients with inadequate conductive hearing from previous middle ear surgery.


Stapes implant

The stapesplasty prosthesis is indicated in cases of congenital or acquired defects of the stapes due to e.g.: *
Otosclerosis Otosclerosis is a condition of the middle ear where portions of the dense enchondral layer of the bony labyrinth remodel into one or more lesions of irregularly-laid spongy bone. As the lesions reach the stapes the bone is resorbed, then har ...
* Congenital fixation of the stapes * Traumatic injury * Malformation of the ossicular chain/middle ear It can also be used to treat patients with inadequate conductive hearing from previous stapes surgery.


References

Medical technology