European Journal of Cardiovascular Medicine

Chronic otitis media (COM) is a common otologic condition in India, frequently associated with hearing loss due to destruction or erosion of the ossicular chain. Along with complete eradication of the disease, preservation and/or improvement of hearing should be a key objective in tympanomastoidectomy procedures to improve patients' quality of life and functional capacity. The goal of ossiculoplasty is to restore the hearing mechanism after eliminating the pathology from the middle ear. Reconstruction of the ossicular chain can be achieved using the patient’s own reshaped ossicles, cartilage grafts, or synthetic prostheses. Autologous materials offer advantages such as excellent biocompatibility, low extrusion rates, affordability, and easy accessibility. However, their limitations include uncertainty regarding the disease-free status of residual ossicles, the potential for resorption, and the need for surgical expertise and time to reshape the prosthesis. The ideal prosthesis for ossicular reconstruction should be biocompatible, stable, safe, easily insertable, and capable of providing optimal sound transmission. The success of ossicular reconstruction depends not only on the characteristics of the prosthesis but also on the local environment and surgical technique. In our study, we utilized ventilation tubes (grommets) as partial ossicular replacement prostheses (PORPs) for reconstructing the ossicular chain, particularly in cases where the stapes was mobile.

This observational study was conducted from July 2023 to July 2024 at Mahaveer Medical College, with a sample size of 20 patients.

Inclusion Criteria: Patients aged between 18 and 60 years of either sex, who provided written informed consent and were diagnosed with chronic otitis media (COM) with conductive hearing loss undergoing canal wall up or canal wall down mastoidectomy with intraoperative ossicular chain erosion and an intact stapes suprastructure were included.

Exclusion Criteria: Patients below 18 or above 60 years of age, those unwilling to give informed consent, cases with stapes suprastructure erosion, history of trauma, prior ear surgeries or revision procedures, presence of aural polyp, extra- or intracranial complications of COM, and those with sensorineural hearing loss were excluded.

All selected patients underwent either canal wall up or down mastoidectomy with Type III tympanoplasty using a 0.9 mm inner diameter Teflon grommet for ossicular reconstruction. Following informed written consent and preoperative pure tone audiometry (PTA), along with routine preoperative investigations, patients were positioned appropriately, and the surgical site was prepared, cleaned, and draped. Local infiltration was given in the postauricular region, followed by a postauricular incision approximately 4 mm behind the crease. The temporalis fascia graft was harvested.

Middle ear access was obtained through a T-shaped incision through the subcutaneous tissue and periosteum to the bone overlying the mastoid. Drilling was initiated in McEwen’s triangle. Based on disease extent, canal wall down mastoidectomy was performed, and disease clearance was ensured. The ossicular chain was assessed, and stapes mobility was confirmed. The fascia graft was then positioned to cover the annulus.

For ossicular reconstruction, the Teflon grommet was placed between the mobile stapes suprastructure and the grafted tympanic membrane. The postauricular incision was closed in a single layer. The external auditory canal was packed with gel foam, and a mastoid dressing was applied.

Postoperatively, antibiotics and analgesics were administered for 10 days. The external auditory canal pack was removed after one week in canal wall down mastoidectomy and after three weeks in canal wall up procedures. Following pack removal, antibiotic ear drops were prescribed once daily for two weeks. Neotympanum was inspected, and patients were followed up weekly for three months to assess graft uptake. Pure tone audiometry was repeated at the end of the third postoperative month. The collected data were analyzed using Microsoft Excel.

Of the 20 patients included in the study, 15 underwent canal wall up (CWU) mastoidectomy with Type III tympanoplasty, and 5 underwent canal wall down (CWD) mastoidectomy with Type III tympanoplasty. Erosion of the incus was noted in 18 cases, while malleus erosion was observed in 3 cases. The mean preoperative air-bone gap was 38 dB, with an average hearing improvement of 12 dB recorded at the third postoperative month.

Among the study participants, 13 were male and 7 were female. The most frequently affected age group was 31–45 years.

With respect to graft uptake, 17 patients demonstrated successful graft integration. Two patients developed residual tympanic membrane perforation, and one case exhibited medialisation of the graft.

In the CWU group (n=15), 4 patients showed a postoperative hearing gain of less than 5 dB, 8 patients achieved a gain of 5–10 dB, and 3 patients demonstrated a gain of 10–15 dB. In the CWD group (n=5), 2 patients had a hearing gain of less than 5 dB, while 3 patients achieved a gain between 5–10 dB.

Intraoperative assessment of the ossicular chain revealed erosion of the long process of the incus in 17 patients. One patient had erosion involving both the incus and malleus (I+M), and 2 patients had erosion isolated to the handle of the malleus.

Chronic otitis media (COM) is frequently associated with conductive hearing loss, primarily due to tympanic membrane perforation and, in some cases, ossicular discontinuity or fixation, necessitating ossiculoplasty to restore auditory function. Among the ossicles, the incus is most commonly affected in COM owing to its fragile anatomy and limited vascular supply. The objective of ossiculoplasty is to re-establish a stable and functional connection between the tympanic membrane and the mobile stapes footplate. Type III tympanoplasty involves placement of an ossicular prosthesis either between the stapes suprastructure (Type IIIa) or directly on the stapes footplate (Type IIIb) and the graft.

For effective sound transmission, ossicular grafts or prostheses must achieve stable coupling to adjacent bone or soft tissue while maintaining suspension in the middle ear space. However, they are susceptible to resorption due to chronic or recurrent infections and extrusion resulting from negative middle ear pressure and Eustachian tube dysfunction. Homografts and synthetic prostheses also carry the risk of immunogenic rejection.

Various autografts, homografts, and synthetic materials have been used for ossicular chain reconstruction. Given the diversity of available prostheses, comparative evaluation is essential. The ideal ossicular prosthesis should be biocompatible, stable, safe, easily accessible, simple to insert, and capable of providing efficient sound conduction. In our study, we utilized Teflon grommets with an internal diameter of 0.9 mm for ossicular reconstruction.

The most prevalent age group in our study was 31 to 45 years, consistent with findings by Chavan et al., who reported a similar mean age in a retrospective study involving 50 patients undergoing ossiculoplasty at a tertiary care center [6]. Our gender distribution (13 males and 7 females) also aligns with Chavan et al.’s prospective study of 80 patients, which demonstrated male predominance [7].

Intraoperatively, erosion of the long process of the incus was observed in 17 patients, isolated malleus erosion in 2, and combined incus and malleus erosion in 1 case. These findings mirror those reported by Chavan et al., where the incus was the most commonly affected ossicle (74 patients), followed by the stapes (29 patients), with the malleus being the most resistant, affected in only 10 cases. This pattern supports the theory that the long process of the incus is most vulnerable due to its tenuous blood supply [7].

Graft uptake was achieved in 85% of cases in our study. Two patients (10%) developed residual perforation, and one patient (5%) had medialisation of the graft. No cases of graft lateralization or cholesteatoma (epithelial pearls) were noted. Preoperative audiometry was performed for all patients, with postoperative pure tone audiometry repeated after three months to evaluate hearing outcomes.

Naragund et al. reported that an average postoperative air-bone gap (ABG) closure of <20 dB was seen in seven cases using autologous incus and in four cases using titanium prostheses [8]. Jha et al. (2007–2009) evaluated ossiculoplasty outcomes using different materials and reported success rates of 57% with cartilage, 58% with incus, and 40% with plastic PORP, in terms of ABG closure [9]. Wiatr et al. demonstrated that using ventilation tubes for ossicular reconstruction resulted in a statistically significant improvement in ABG (p=0.046) within six months postoperatively [10].

In our study, among the 15 patients who underwent CWU mastoidectomy, 4 patients (26%) had a hearing gain of <5 dB, 8 patients (53.3%) had a gain of 5–10 dB, and 3 patients (20%) showed a gain of 10–15 dB. Among the 5 patients who underwent CWD mastoidectomy, 2 (40%) had a gain of <5 dB, while 3 (60%) had a gain between 5–10 dB.

The use of a grommet tube as a partial ossicular replacement prosthesis (PORP) is an effective and economical alternative for ossicular chain reconstruction in Type III tympanoplasty. Its favorable shape and size allow secure placement over the stapes head, contributing to low extrusion rates. Given its cost-effectiveness and satisfactory hearing outcomes, the Teflon grommet serves as a viable prosthetic option in selected cases of ossiculoplasty.

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